Trial Outcomes & Findings for An Open Label Dose Escalation Study Of E7080 (NCT NCT00121719)
NCT ID: NCT00121719
Last Updated: 2023-06-22
Results Overview
The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
Cycle 1 (4 weeks)
Results posted on
2023-06-22
Participant Flow
Participants took part in the study at 1 site in United Kingdom and 1 site in Netherlands from 01 July 2005 to 01 March 2019.
A total of 82 participants with solid tumors or lymphomas were enrolled and received study treatment.
Participant milestones
| Measure |
Lenvatinib 0.2 mg
Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.4 mg
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation (4 Weeks)
STARTED
|
4
|
4
|
4
|
3
|
3
|
3
|
12
|
9
|
6
|
3
|
0
|
0
|
24
|
7
|
|
Dose Escalation (4 Weeks)
COMPLETED
|
4
|
4
|
4
|
3
|
3
|
3
|
12
|
9
|
6
|
3
|
0
|
0
|
24
|
7
|
|
Dose Escalation (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Food-Effect Pilot Study (4 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
5
|
0
|
0
|
|
Food-Effect Pilot Study (4 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
5
|
0
|
0
|
|
Food-Effect Pilot Study (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label Dose Escalation Study Of E7080
Baseline characteristics by cohort
| Measure |
Lenvatinib 0.2 mg
n=4 Participants
Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib (MTD Cohort) 25 mg
n=24 Participants
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
n=7 Participants
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
47.8 Years
STANDARD_DEVIATION 6.45 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
60.0 Years
STANDARD_DEVIATION 11.53 • n=4 Participants
|
65.0 Years
STANDARD_DEVIATION 19.00 • n=21 Participants
|
51.0 Years
STANDARD_DEVIATION 22.72 • n=10 Participants
|
46.3 Years
STANDARD_DEVIATION 13.25 • n=115 Participants
|
52.6 Years
STANDARD_DEVIATION 13.28 • n=24 Participants
|
55.7 Years
STANDARD_DEVIATION 13.32 • n=42 Participants
|
51.7 Years
STANDARD_DEVIATION 12.34 • n=42 Participants
|
52.2 Years
STANDARD_DEVIATION 9.65 • n=42 Participants
|
53.9 Years
STANDARD_DEVIATION 11.84 • n=42 Participants
|
53.4 Years
STANDARD_DEVIATION 12.32 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
39 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
43 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (4 weeks)Population: ITT population included all participants who received at least one dose of lenvatinib.
The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.
Outcome measures
| Measure |
Lenvatinib
n=82 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
25 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First date of study treatment to date of last dose of study treatment, up to approximately 13 years and 8 monthsPopulation: Safety population (ITT population) included all participants who received at least one dose of lenvatinib.
All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. Treatment-related AEs and SAEs are AEs considered probably or possibly related to lenvatinib.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=6 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=5 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
n=24 Participants
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
n=7 Participants
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related adverse events
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
91.7 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
85.7 Percentage of participants
|
|
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious adverse events
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
33.3 Percentage of participants
|
0 Percentage of participants
|
100.0 Percentage of participants
|
41.7 Percentage of participants
|
44.4 Percentage of participants
|
33.3 Percentage of participants
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
40.0 Percentage of participants
|
62.5 Percentage of participants
|
42.9 Percentage of participants
|
|
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related serious adverse events
|
25.0 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
8.3 Percentage of participants
|
11.1 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
16.7 Percentage of participants
|
20.0 Percentage of participants
|
33.3 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 (4 weeks) of each dose levelPopulation: ITT/ safety population included all participants who received at least one dose of lenvatinib.
A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-limiting Toxicities (DLTs)
Proteinuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Dose-limiting Toxicities (DLTs)
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-limiting Toxicities (DLTs)
Febrile neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-limiting Toxicities (DLTs)
Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
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0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
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0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-limiting Toxicities (DLTs)
Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
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0 Participants
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0 Participants
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0 Participants
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—
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—
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SECONDARY outcome
Timeframe: First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 13 years and 8 monthsPopulation: Safety population (ITT population) included all participants who took at least one dose of lenvatinib.
Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.
Outcome measures
| Measure |
Lenvatinib
n=21 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=30 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=24 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=7 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Nausea
|
38 Percentage of participants
|
17 Percentage of participants
|
58 Percentage of participants
|
43 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Headache
|
0 Percentage of participants
|
7 Percentage of participants
|
29 Percentage of participants
|
29 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Hypertension
|
10 Percentage of participants
|
40 Percentage of participants
|
63 Percentage of participants
|
57 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Diarrhoea
|
19 Percentage of participants
|
27 Percentage of participants
|
50 Percentage of participants
|
57 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Stomatitis
|
5 Percentage of participants
|
20 Percentage of participants
|
63 Percentage of participants
|
57 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Proteinuria
|
14 Percentage of participants
|
27 Percentage of participants
|
29 Percentage of participants
|
43 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Vomiting
|
33 Percentage of participants
|
10 Percentage of participants
|
33 Percentage of participants
|
14 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Lethargy
|
14 Percentage of participants
|
17 Percentage of participants
|
38 Percentage of participants
|
29 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Dysphonia
|
0 Percentage of participants
|
13 Percentage of participants
|
46 Percentage of participants
|
43 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Dry skin
|
5 Percentage of participants
|
10 Percentage of participants
|
46 Percentage of participants
|
14 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Fatigue
|
10 Percentage of participants
|
23 Percentage of participants
|
21 Percentage of participants
|
14 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Anorexia
|
10 Percentage of participants
|
17 Percentage of participants
|
21 Percentage of participants
|
29 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Constipation
|
10 Percentage of participants
|
10 Percentage of participants
|
33 Percentage of participants
|
14 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%
Abdominal pain
|
0 Percentage of participants
|
7 Percentage of participants
|
29 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 yearsPopulation: ITT population included all participants who received at least one dose of lenvatinib.
BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at 7 weeks or later after starting lenvatinib.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
Progressive disease
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
41.7 Percentage of participants
|
11.1 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Best Overall Response (BOR)
Partial response
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
12.5 Percentage of participants
|
28.6 Percentage of participants
|
—
|
—
|
|
Best Overall Response (BOR)
Stable disease
|
0 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
55.6 Percentage of participants
|
83.3 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
42.9 Percentage of participants
|
—
|
—
|
|
Best Overall Response (BOR)
Not evaluable
|
25.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: Pharmacokinetic (PK) population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Lenvatinib
Cycle 1 Day 1
|
0.753 Nanogram per milliliter (ng/mL)
Standard Deviation 0.2176
|
1.740 Nanogram per milliliter (ng/mL)
Standard Deviation 0.6921
|
4.255 Nanogram per milliliter (ng/mL)
Standard Deviation 1.7474
|
20.967 Nanogram per milliliter (ng/mL)
Standard Deviation 11.6741
|
49.883 Nanogram per milliliter (ng/mL)
Standard Deviation 15.9952
|
127.067 Nanogram per milliliter (ng/mL)
Standard Deviation 91.3320
|
259.990 Nanogram per milliliter (ng/mL)
Standard Deviation 108.1789
|
209.004 Nanogram per milliliter (ng/mL)
Standard Deviation 112.0090
|
375.077 Nanogram per milliliter (ng/mL)
Standard Deviation 158.1811
|
408.797 Nanogram per milliliter (ng/mL)
Standard Deviation 105.6923
|
630.589 Nanogram per milliliter (ng/mL)
Standard Deviation 234.1659
|
649.927 Nanogram per milliliter (ng/mL)
Standard Deviation 237.7462
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Lenvatinib
Cycle 2 Day 1
|
2.385 Nanogram per milliliter (ng/mL)
Standard Deviation 0.5162
|
5.477 Nanogram per milliliter (ng/mL)
Standard Deviation 1.5988
|
9.610 Nanogram per milliliter (ng/mL)
Standard Deviation 2.3193
|
36.483 Nanogram per milliliter (ng/mL)
Standard Deviation 10.9339
|
92.137 Nanogram per milliliter (ng/mL)
Standard Deviation 29.0365
|
197.217 Nanogram per milliliter (ng/mL)
Standard Deviation 136.7307
|
291.414 Nanogram per milliliter (ng/mL)
Standard Deviation 146.1972
|
187.467 Nanogram per milliliter (ng/mL)
Standard Deviation 86.3962
|
368.937 Nanogram per milliliter (ng/mL)
Standard Deviation 148.8160
|
238.670 Nanogram per milliliter (ng/mL)
Standard Deviation NA
not evaluable, n=1
|
544.718 Nanogram per milliliter (ng/mL)
Standard Deviation 183.1259
|
562.416 Nanogram per milliliter (ng/mL)
Standard Deviation 121.4056
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Lenvatinib
Cycle 1 Day 1
|
4.280 Hours
Standard Deviation 1.440
|
5.785 Hours
Standard Deviation 2.569
|
3.263 Hours
Standard Deviation 1.194
|
3.973 Hours
Standard Deviation 3.494
|
9.557 Hours
Standard Deviation 12.658
|
2.023 Hours
Standard Deviation 1.035
|
2.348 Hours
Standard Deviation 1.144
|
1.897 Hours
Standard Deviation 0.7768
|
2.287 Hours
Standard Deviation 0.3881
|
2.533 Hours
Standard Deviation 0.826
|
1.770 Hours
Standard Deviation 0.715
|
2.674 Hours
Standard Deviation 2.038
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Lenvatinib
Cycle 2 Day 1
|
2.225 Hours
Standard Deviation 0.3889
|
2.680 Hours
Standard Deviation 0.589
|
13.475 Hours
Standard Deviation 14.814
|
2.360 Hours
Standard Deviation 1.179
|
2.173 Hours
Standard Deviation 0.583
|
2.103 Hours
Standard Deviation 0.405
|
2.021 Hours
Standard Deviation 1.295
|
1.944 Hours
Standard Deviation 0.604
|
2.352 Hours
Standard Deviation 0.705
|
3.000 Hours
Standard Deviation NA
not evaluable n=1
|
2.983 Hours
Standard Deviation 1.481
|
1.500 Hours
Standard Deviation 0.408
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=11 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Plasma Half-life (t1/2) of Lenvatinib
Cycle 2 Day 1
|
29.540 Hours
Standard Deviation 8.2731
|
26.380 Hours
Standard Deviation 8.0427
|
20.840 Hours
Standard Deviation NA
Not evaluable n=1
|
10.827 Hours
Standard Deviation 5.555
|
9.973 Hours
Standard Deviation 1.288
|
8.330 Hours
Standard Deviation 0.517
|
6.935 Hours
Standard Deviation 1.1681
|
6.829 Hours
Standard Deviation 1.019
|
6.935 Hours
Standard Deviation 0.9313
|
8.090 Hours
Standard Deviation NA
Not evaluable n=1
|
6.025 Hours
Standard Deviation 0.704
|
6.675 Hours
Standard Deviation 0.5216
|
—
|
—
|
|
Apparent Plasma Half-life (t1/2) of Lenvatinib
Cycle 1 Day 1
|
—
|
—
|
18.180 Hours
Standard Deviation 11.342
|
10.695 Hours
Standard Deviation 8.789
|
12.805 Hours
Standard Deviation 3.118
|
8.077 Hours
Standard Deviation 0.749
|
5.981 Hours
Standard Deviation 0.4840
|
6.567 Hours
Standard Deviation 0.9553
|
7.115 Hours
Standard Deviation 1.0866
|
6.960 Hours
Standard Deviation 1.230
|
5.848 Hours
Standard Deviation 1.018
|
5.550 Hours
Standard Deviation 0.599
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))
Cycle 1 Day 1
|
—
|
—
|
123.745 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 20.810
|
376.645 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 312.1240
|
780.275 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 189.116
|
1335.493 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 894.562
|
1895.454 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 467.145
|
1693.298 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1011.7941
|
3683.590 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2210.4521
|
4238.680 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2602.9271
|
4413.263 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1946.571
|
4383.678 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1697.248
|
—
|
—
|
|
Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))
Cycle 2 Day 1
|
99.325 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 0.1202
|
174.310 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 46.259
|
370.390 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation NA
Not evaluable n=1
|
585.247 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 397.909
|
1150.393 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 192.365
|
1952.430 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1323.783
|
2278.016 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 851.258
|
1558.101 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 760.687
|
3310.673 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1544.708
|
2260.040 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation NA
Not evaluable n=1
|
4549.825 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1161.045
|
4391.160 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 997.486
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))
Cycle 1 Day 1
|
14.348 ng*hr/mL
Standard Deviation 4.500
|
30.207 ng*hr/mL
Standard Deviation 14.521
|
61.915 ng*hr/mL
Standard Deviation 17.164
|
220.910 ng*hr/mL
Standard Deviation 129.838
|
659.553 ng*hr/mL
Standard Deviation 209.129
|
1168.257 ng*hr/mL
Standard Deviation 799.169
|
1655.035 ng*hr/mL
Standard Deviation 555.479
|
1537.476 ng*hr/mL
Standard Deviation 876.6805
|
3250.843 ng*hr/mL
Standard Deviation 1826.8789
|
3709.550 ng*hr/mL
Standard Deviation 2059.6379
|
4074.803 ng*hr/mL
Standard Deviation 1666.2780
|
4601.014 ng*hr/mL
Standard Deviation 1887.3642
|
—
|
—
|
|
Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))
Cycle 2 Day 1
|
43.305 ng*hr/mL
Standard Deviation 8.5913
|
85.477 ng*hr/mL
Standard Deviation 37.054
|
199.100 ng*hr/mL
Standard Deviation NA
Not evaluable n=1
|
422.873 ng*hr/mL
Standard Deviation 270.528
|
931.307 ng*hr/mL
Standard Deviation 179.514
|
1691.160 ng*hr/mL
Standard Deviation 1167.750
|
2052.965 ng*hr/mL
Standard Deviation 789.504
|
1422.584 ng*hr/mL
Standard Deviation 697.699
|
2947.920 ng*hr/mL
Standard Deviation 1286.805
|
1934.500 ng*hr/mL
Standard Deviation NA
Not evaluable n=1
|
4224.095 ng*hr/mL
Standard Deviation 1120.837
|
4020.185 ng*hr/mL
Standard Deviation 899.182
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)
Cycle 1 Day 1
|
—
|
—
|
6.560 Liter per hour (L/hr)
Standard Deviation 1.103
|
6.470 Liter per hour (L/hr)
Standard Deviation 5.360
|
4.225 Liter per hour (L/hr)
Standard Deviation 1.0253
|
8.190 Liter per hour (L/hr)
Standard Deviation 7.923
|
6.614 Liter per hour (L/hr)
Standard Deviation 1.336
|
9.534 Liter per hour (L/hr)
Standard Deviation 4.307
|
6.157 Liter per hour (L/hr)
Standard Deviation 4.240
|
5.980 Liter per hour (L/hr)
Standard Deviation 3.236
|
6.863 Liter per hour (L/hr)
Standard Deviation 3.354
|
8.827 Liter per hour (L/hr)
Standard Deviation 5.058
|
—
|
—
|
|
Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)
Cycle 2 Day 1
|
4.710 Liter per hour (L/hr)
Standard Deviation 0.9334
|
5.200 Liter per hour (L/hr)
Standard Deviation 1.802
|
4.020 Liter per hour (L/hr)
Standard Deviation NA
Not evaluable n=1
|
5.347 Liter per hour (L/hr)
Standard Deviation 3.942
|
3.533 Liter per hour (L/hr)
Standard Deviation 0.747
|
5.557 Liter per hour (L/hr)
Standard Deviation 4.200
|
6.896 Liter per hour (L/hr)
Standard Deviation 3.360
|
10.110 Liter per hour (L/hr)
Standard Deviation 3.321
|
6.437 Liter per hour (L/hr)
Standard Deviation 3.668
|
10.340 Liter per hour (L/hr)
Standard Deviation NA
Not evaluable n=1
|
6.378 Liter per hour (L/hr)
Standard Deviation 2.302
|
7.978 Liter per hour (L/hr)
Standard Deviation 2.763
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
Cycle 1 Day 1
|
—
|
—
|
162.975 Liter (L)
Standard Deviation 78.383
|
65.795 Liter (L)
Standard Deviation 0.6435
|
80.365 Liter (L)
Standard Deviation 37.922
|
97.190 Liter (L)
Standard Deviation 95.442
|
57.039 Liter (L)
Standard Deviation 11.887
|
88.069 Liter (L)
Standard Deviation 38.174
|
58.408 Liter (L)
Standard Deviation 32.346
|
56.350 Liter (L)
Standard Deviation 22.932
|
55.263 Liter (L)
Standard Deviation 22.411
|
68.073 Liter (L)
Standard Deviation 32.456
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F)
Cycle 2 Day 1
|
206.360 Liter (L)
Standard Deviation 96.068
|
208.937 Liter (L)
Standard Deviation 114.969
|
120.810 Liter (L)
Standard Deviation NA
Not evaluable n=1
|
65.437 Liter (L)
Standard Deviation 24.894
|
51.487 Liter (L)
Standard Deviation 16.805
|
67.747 Liter (L)
Standard Deviation 51.897
|
70.881 Liter (L)
Standard Deviation 40.419
|
99.960 Liter (L)
Standard Deviation 37.787
|
60.683 Liter (L)
Standard Deviation 26.763
|
120.730 Liter (L)
Standard Deviation NA
Not evaluable n=1
|
57.143 Liter (L)
Standard Deviation 28.550
|
76.610 Liter (L)
Standard Deviation 25.967
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)
Cycle 1 Day 1
|
0.530 Percentage of lenvatinib
Standard Deviation 0.0141
|
0.253 Percentage of lenvatinib
Standard Deviation 0.0457
|
0.217 Percentage of lenvatinib
Standard Deviation 0.0896
|
0.363 Percentage of lenvatinib
Standard Deviation 0.1290
|
0.355 Percentage of lenvatinib
Standard Deviation 0.0354
|
0.390 Percentage of lenvatinib
Standard Deviation 0.0849
|
0.487 Percentage of lenvatinib
Standard Deviation 0.3137
|
0.783 Percentage of lenvatinib
Standard Deviation 0.7928
|
0.348 Percentage of lenvatinib
Standard Deviation 0.1910
|
0.690 Percentage of lenvatinib
Standard Deviation 0.4851
|
0.576 Percentage of lenvatinib
Standard Deviation 0.3042
|
0.503 Percentage of lenvatinib
Standard Deviation 0.3004
|
—
|
—
|
|
Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)
Cycle 2 Day 1
|
1.240 Percentage of lenvatinib
Standard Deviation NA
Not evaluable n=1
|
0.715 Percentage of lenvatinib
Standard Deviation 0.1626
|
0.605 Percentage of lenvatinib
Standard Deviation 0.0636
|
0.535 Percentage of lenvatinib
Standard Deviation 0.3748
|
1.050 Percentage of lenvatinib
Standard Deviation NA
Not evaluable n=1
|
0.557 Percentage of lenvatinib
Standard Deviation 0.2212
|
0.689 Percentage of lenvatinib
Standard Deviation 0.4208
|
0.663 Percentage of lenvatinib
Standard Deviation 0.2873
|
0.825 Percentage of lenvatinib
Standard Deviation 0.2786
|
0.630 Percentage of lenvatinib
Standard Deviation NA
Not evaluable n=1
|
0.778 Percentage of lenvatinib
Standard Deviation 0.3801
|
0.527 Percentage of lenvatinib
Standard Deviation 0.1595
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)Population: PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.
Outcome measures
| Measure |
Lenvatinib
n=4 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=4 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 Participants
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 Participants
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 Participants
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 Participants
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 Participants
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 Participants
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 Participants
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 Participants
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=24 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=7 Participants
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) of Lenvatinib
Cycle 1 Day 1
|
0.060 L/hour
Standard Deviation 0.0064
|
0.037 L/hour
Standard Deviation 0.0167
|
0.027 L/hour
Standard Deviation 0.0042
|
0.035 L/hour
Standard Deviation 0.0233
|
0.021 L/hour
Standard Deviation 0.0113
|
0.017 L/hour
Standard Deviation 0.0078
|
0.039 L/hour
Standard Deviation 0.0243
|
0.064 L/hour
Standard Deviation 0.0534
|
0.020 L/hour
Standard Deviation 0.0095
|
0.046 L/hour
Standard Deviation 0.0466
|
0.041 L/hour
Standard Deviation 0.0233
|
0.035 L/hour
Standard Deviation 0.0144
|
—
|
—
|
|
Renal Clearance (CLr) of Lenvatinib
Cycle 2 Day 1
|
0.050 L/hour
Standard Deviation NA
Not evaluable n=1
|
0.045 L/hour
Standard Deviation 0.011
|
0.022 L/hour
Standard Deviation NA
Not evaluable n=1
|
0.029 L/hour
Standard Deviation 0.0042
|
0.034 L/hour
Standard Deviation NA
Not evaluable n=1
|
0.025 L/hour
Standard Deviation 0.0097
|
0.050 L/hour
Standard Deviation 0.0304
|
0.069 L/hour
Standard Deviation 0.021
|
0.048 L/hour
Standard Deviation 0.36
|
0.065 L/hour
Standard Deviation NA
Not evaluable n=1
|
0.52 L/hour
Standard Deviation 0.019
|
0.045 L/hour
Standard Deviation 0.0247
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 and Day 22: 0-24 hours postdose (Cycle length = 28 days)Population: The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.
Outcome measures
| Measure |
Lenvatinib
n=11 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=11 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
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Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))
|
3851.773 ng*hr/mL
Standard Deviation 993.1449
|
4039.681 ng*hr/mL
Standard Deviation 1567.4169
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SECONDARY outcome
Timeframe: Cycle 1 Day 15 and Day 22: 0-24 hours postdose (Cycle length = 28 days)Population: The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.
Outcome measures
| Measure |
Lenvatinib
n=11 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=11 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib
|
508.558 ng/mL
Standard Deviation 165.7591
|
544.058 ng/mL
Standard Deviation 248.5409
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SECONDARY outcome
Timeframe: Cycle 1 Day 15 and Day 22: 0-24 hours postdose (Cycle length = 28 days)Population: The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.
Outcome measures
| Measure |
Lenvatinib
n=11 Participants
Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.
Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.
|
Lenvatinib 0.4 mg
n=11 Participants
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib
|
4.980 Hours
Interval 2.0 to 5.07
|
2.030 Hours
Interval 1.0 to 3.07
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OTHER_PRE_SPECIFIED outcome
Timeframe: Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatmentPopulation: No appropriate PD biomarker in PBMC, therefore we did not have any biomarker analysis for PK/PD analysis.
Based on the data in assay development stage before PD biomarker analysis in study E7080-E044-101 we did not find the appropriate PD biomarker in PBMC, therefore we did not have any biomarker analysis for PK/PD analysis.
Outcome measures
Outcome data not reported
Adverse Events
Lenvatinib 0.2 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Lenvatinib 0.4 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Lenvatinib 0.8 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Lenvatinib 1.6 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Lenvatinib 3.2 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lenvatinib 6.4 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Lenvatinib 12 mg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Lenvatinib 12.5 mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Lenvatinib 16 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Lenvatinib 20 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Lenvatinib Fasted/Fed 25 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Lenvatinib Fed/Fasted 25 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Lenvatinib (MTD Cohort) 25 mg
Serious events: 15 serious events
Other events: 24 other events
Deaths: 3 deaths
Lenvatinib 32 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lenvatinib 0.2 mg
n=4 participants at risk
Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.4 mg
n=4 participants at risk
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 participants at risk
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 participants at risk
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 participants at risk
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 participants at risk
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 participants at risk
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 participants at risk
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 participants at risk
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 participants at risk
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=6 participants at risk
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=5 participants at risk
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
n=24 participants at risk
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
n=7 participants at risk
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Malaise
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Performance status decreased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Abscess
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Groin infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Thrombosis
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Chest pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
Other adverse events
| Measure |
Lenvatinib 0.2 mg
n=4 participants at risk
Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.4 mg
n=4 participants at risk
Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 0.8 mg
n=4 participants at risk
Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 1.6 mg
n=3 participants at risk
One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 3.2 mg
n=3 participants at risk
Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 6.4 mg
n=3 participants at risk
Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12 mg
n=12 participants at risk
One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 12.5 mg
n=9 participants at risk
One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 16 mg
n=6 participants at risk
One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 20 mg
n=3 participants at risk
Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib Fasted/Fed 25 mg
n=6 participants at risk
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib Fed/Fasted 25 mg
n=5 participants at risk
Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
|
Lenvatinib (MTD Cohort) 25 mg
n=24 participants at risk
Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
Lenvatinib 32 mg
n=7 participants at risk
Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
41.7%
10/24 • Number of events 14 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
4/6 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
8/24 • Number of events 13 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
60.0%
3/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
29.2%
7/24 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Chest pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
4/24 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Chills
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Malaise
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Feeling cold
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Impaired healing
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
General disorders
Oedema
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
3/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
29.2%
7/24 • Number of events 10 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
4/24 • Number of events 12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
4/6 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
60.0%
3/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
12/24 • Number of events 14 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
75.0%
3/4 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.8%
5/24 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
4/6 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
29.2%
7/24 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.8%
5/24 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.8%
5/24 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Groin infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
45.8%
11/24 • Number of events 15 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
41.7%
5/12 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
4/6 • Number of events 11 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
4/6 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
62.5%
15/24 • Number of events 24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
57.1%
4/7 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
44.4%
4/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
60.0%
3/5 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
12/24 • Number of events 19 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
3/6 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
29.2%
7/24 • Number of events 22 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 19 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
6/24 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Occult blood
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Splinter haemorrhages
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 10 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Eye disorders
Blindness
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Investigations
Liver function test increased
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Nail discomfort
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Surgical and medical procedures
Wound closure
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
75.0%
3/4 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
2/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
100.0%
3/3 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
2/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
100.0%
3/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
4/6 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
100.0%
5/5 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
70.8%
17/24 • Number of events 29 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
42.9%
3/7 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
2/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
3/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
100.0%
3/3 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
83.3%
5/6 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
80.0%
4/5 • Number of events 12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
16/24 • Number of events 36 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
57.1%
4/7 • Number of events 12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
3/6 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
83.3%
5/6 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
60.0%
3/5 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
62.5%
15/24 • Number of events 23 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
57.1%
4/7 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
2/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
100.0%
3/3 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
4/12 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
44.4%
4/9 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
80.0%
4/5 • Number of events 9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
54.2%
13/24 • Number of events 28 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
6/12 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
60.0%
3/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
54.2%
13/24 • Number of events 20 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
50.0%
2/4 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
60.0%
3/5 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
41.7%
10/24 • Number of events 17 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
4/24 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.8%
5/24 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
25.0%
1/4 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Lethargy
|
25.0%
1/4 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
66.7%
2/3 • Number of events 8 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
3/12 • Number of events 5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
41.7%
10/24 • Number of events 21 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
28.6%
2/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
3/9 • Number of events 4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
37.5%
9/24 • Number of events 18 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
57.1%
4/7 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
25.0%
1/4 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
40.0%
2/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
12.5%
3/24 • Number of events 7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
2/24 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
14.3%
1/7 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
20.0%
1/5 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
4.2%
1/24 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
33.3%
1/3 • Number of events 2 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/4 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/12 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/9 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
16.7%
1/6 • Number of events 1 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/3 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/6 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/5 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/24 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
0.00%
0/7 • All adverse events (AEs) were collected for up to approximately 13 years and 8 months
Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place