Trial Outcomes & Findings for A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma (NCT NCT01790503)
NCT ID: NCT01790503
Last Updated: 2020-06-30
Results Overview
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
Results posted on
2020-06-30
Participant Flow
A total of 65 participants (22 in Phase 1b; 43 in Phase 2) who met all inclusion criteria and no exclusion criteria were enrolled and treated in the study at 10 clinic sites in the United States.
This study included Phase 1b dose escalation where 5 cohorts were planned to be enrolled, each with approximately 7 participants (3+3 design) and Phase 2 where 37 participants were planned to be enrolled with the 7 participants treated at the RP2D level determined in the Phase 1b dose escalation phase yielding approximately 44 participants.
Participant milestones
| Measure |
Phase 1b Dose Escalation - 600 mg/600 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/800 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter
|
Phase 1b Dose Escalation - 600 mg/1000 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (5 Days)
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (7 Days)
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
|
Phase 2 - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 2 - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
1
|
2
|
5
|
5
|
1
|
1
|
3
|
27
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
2
|
5
|
5
|
1
|
1
|
3
|
26
|
16
|
Reasons for withdrawal
| Measure |
Phase 1b Dose Escalation - 600 mg/600 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/800 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter
|
Phase 1b Dose Escalation - 600 mg/1000 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (5 Days)
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (7 Days)
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
|
Phase 2 - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 2 - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
2
|
1
|
0
|
1
|
2
|
1
|
0
|
1
|
0
|
17
|
7
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Non Compliance
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
Baseline Characteristics
A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
Baseline characteristics by cohort
| Measure |
Phase 1b Dose Escalation - 600 mg/600 mg
n=3 Participants
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/800 mg
n=1 Participants
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/1000 mg
n=1 Participants
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg
n=2 Participants
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter
|
Phase 1b Dose Escalation - 800 mg/1000 mg
n=5 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (5 Days)
n=5 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
n=1 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
n=1 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg (7 Days)
n=3 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
|
Phase 2 - 800 mg/800 mg
n=27 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 2 - 800 mg
n=16 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
11 Participants
n=95 Participants
|
37 Participants
n=129 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
20 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
28 Participants
n=129 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
23.0 years
STANDARD_DEVIATION 0 • n=4 Participants
|
73 years
STANDARD_DEVIATION 0 • n=27 Participants
|
48.0 years
STANDARD_DEVIATION 17.0 • n=483 Participants
|
50.8 years
STANDARD_DEVIATION 15.7 • n=36 Participants
|
60.8 years
STANDARD_DEVIATION 8.6 • n=10 Participants
|
30.0 years
STANDARD_DEVIATION 0 • n=115 Participants
|
51.0 years
STANDARD_DEVIATION 0 • n=40 Participants
|
53.3 years
STANDARD_DEVIATION 4.2 • n=8 Participants
|
55.7 years
STANDARD_DEVIATION 10.8 • n=62 Participants
|
59.0 years
STANDARD_DEVIATION 10.7 • n=95 Participants
|
55.3 years
STANDARD_DEVIATION 11.9 • n=129 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
24 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=62 Participants
|
9 Participants
n=95 Participants
|
41 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
25 Participants
n=62 Participants
|
16 Participants
n=95 Participants
|
58 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
5 participants
n=36 Participants
|
5 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=40 Participants
|
3 participants
n=8 Participants
|
27 participants
n=62 Participants
|
16 participants
n=95 Participants
|
65 participants
n=129 Participants
|
PRIMARY outcome
Timeframe: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.Population: mPFS was assessed in the modified intent-to-treat RP2D and the per protocol (PP) populations.
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group
PP RP2D
|
6.9 months
Interval 4.5 to 10.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group
mITT RP2D
|
6.7 months
Interval 4.5 to 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.Population: mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.
mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
n=43 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
n=49 Participants
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
n=43 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature
|
7.7 months
Interval 5.6 to 10.4
|
7.6 months
Interval 5.5 to 10.6
|
7.0 months
Interval 5.1 to 9.5
|
6.1 months
Interval 4.4 to 8.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.Population: mPFS was assessed in the mITT RP2D population.
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT). The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age: 18-64 years
|
6 months
Interval 4.5 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age: 65+ years
|
10 months
Interval 2.7 to 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Extent of surgery: complete resection
|
6 months
Interval 4.2 to 12.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Extent of surgery: partial resection
|
9 months
Interval 4.5 to 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89
|
4 months
Interval 2.6 to 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100
|
11 months
Interval 6.2 to 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated
|
10 months
Interval 5.2 to 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated
|
4 months
Interval 3.9 to 10.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 monthsPopulation: OS was assessed in the mITT RP2D and PP RP2D populations.
Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Overall Survival in The Study Population
PP RP2D
|
12.4 months
Interval 9.9 to
In Kaplan-Meier analysis, the upper limit of median survival's confidence interval is non-estimable (NE) when the upper confidence interval curve does not drop to or below the 50% line
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival in The Study Population
mITT RP2D
|
13.1 months
Interval 11.5 to 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.Population: Median OS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.
Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
n=43 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
n=49 Participants
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
n=43 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature
|
18.8 months
Interval 12.6 to 28.0
|
20.2 months
Interval 12.9 to 31.6
|
17.0 months
Interval 11.3 to 25.6
|
16.9 months
Interval 10.8 to 26.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.Population: OS was assessed in the mITT RP2D population.
Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT). The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years
|
14.3 months
Interval 12.3 to
In Kaplan-Meier analysis, the upper limit of median survival's confidence interval is non-estimable (NE) when the upper confidence interval curve does not drop to or below the 50% line
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years
|
11 months
Interval 4.3 to 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Extent of surgery: complete resection
|
14 months
Interval 9.9 to 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Extent of surgery: partial resection
|
13 months
Interval 7.9 to 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Basline KPS: 70-89
|
8 months
Interval 6.9 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100
|
24 months
Interval 13.1 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated
|
15 months
Interval 9.7 to 15.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT: unmethylated
|
12 months
Interval 7.9 to 20.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from Baseline and every 8 weeks, up to 4 years 4 monthsPopulation: Best Overall Response was assessed in the mITT RP2D population.
Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), \>=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, \>25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=53 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · Partial response (PR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · CR+PR
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · Stable disease
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · Progressive disease
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · Complete response (CR)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · Partial response (PR)
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · CR+PR
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · Stable disease
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · Partial response (PR)
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · Stable disease
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · Progressive disease
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · CR+PR
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · Progressive disease
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · Complete response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · Partial response (PR)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · CR+PR
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · Stable disease
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · Progressive disease
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · Complete response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Complete resection · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · Partial response (PR)
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · CR+PR
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · Stable disease
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · Progressive disease
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Partial resection · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 70-89 · Complete response (CR)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · Progressive disease
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Baseline KPS: 90-100 · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · Complete response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · Partial response (PR)
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · CR+PR
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · Stable disease
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · Progressive disease
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: methylated · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · Complete response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · Partial response (PR)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · CR+PR
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · Stable disease
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · Progressive disease
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · Complete response (CR)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 18-64 years · CR+PR
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · Complete response (CR)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · Partial response (PR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Age group: 65+ years · Stable disease
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · Unable to access
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
MGMT status: unmethylated · Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 4 years 4 monthsPopulation: Safety was assessed in the mITT population.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=3 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
n=1 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
n=1 Participants
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
n=2 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
n=5 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
n=5 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
n=1 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
n=1 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
n=3 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
General Disorders and Administrative Site
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Nervous System Disorders
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Skin and Subcutaneous Tissue Disorders
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Gastrointestinal Disorders
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Metabolism and Nutrition Disorders
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Psychiatric Disorders
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Infections and Infestations
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Investigations
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Respiratory, Thoracic, and Mediastinal Disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Musculoskeletal and Connective Tissue Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Blood and Lymphatic Tissue Disorders
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Vascular Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Renal and Urinary Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Eye Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Injury, Poisoning, and Procedural Complications
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Ear and Labyrinth
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Endocrine Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Cardiac Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Hepatobiliary Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Reproductive System and Breast Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Immune System Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Neoplasms Benign, Malignant, and Unspecified
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 4 years 4 monthsPopulation: Safety was assessed in the mITT population.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=27 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
n=16 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
n=43 Participants
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
n=53 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Injury, Poisoning, and Procedural Complications
|
10 Participants
|
6 Participants
|
16 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Eye Disorders
|
7 Participants
|
6 Participants
|
13 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Blood and Lymphatic System Disorders
|
14 Participants
|
2 Participants
|
16 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
General Disorders and Administration Site
|
24 Participants
|
13 Participants
|
37 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Skin and Subcutaneous Tissue Disorders
|
24 Participants
|
12 Participants
|
36 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Nervous System Disorders
|
22 Participants
|
12 Participants
|
34 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Gastrointestinal Disorders
|
21 Participants
|
12 Participants
|
33 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Metabolism and Nutrition Disorders
|
16 Participants
|
8 Participants
|
24 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Psychiatric Disorders
|
17 Participants
|
6 Participants
|
23 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Investigations
|
12 Participants
|
9 Participants
|
21 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Musculoskeletal and Connective Tissue Disorders
|
13 Participants
|
7 Participants
|
20 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Vascular Disorders
|
9 Participants
|
4 Participants
|
13 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Respiratory, Thoracic, and Mediastinal Disorders
|
7 Participants
|
3 Participants
|
10 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Renal and Urinary Disorders
|
7 Participants
|
2 Participants
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Cardiac Disorders
|
5 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Endocrine Disorders
|
5 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Ear and Labyrinth Disorders
|
3 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Reproductive System and Breast Disorders
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Neoplasms Benign, Malignant, and Unspecified
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Hepatobiliary Disorders
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Immune System Disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 4 years 4 monthsPopulation: Abnormal chemistry and hematology values were assessed in the mITT population.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=3 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
n=1 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
n=1 Participants
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
n=2 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
n=5 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
n=5 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
n=1 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
n=1 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
n=3 Participants
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
White blood cell decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Thrombocytopenia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Neutropenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Anaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Lymphopenia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
AST increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Neutrophil count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Leukopenia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Febrile neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
ALT increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Bone marrow failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Haemolysis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 4 years 4 monthsPopulation: Abnormal chemistry and hematology values were assessed in the mITT population.
Outcome measures
| Measure |
Combined 800 mg, 5 Days/Week
n=27 Participants
All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.
|
RP2D-0525 (Cycle 1, Day 1)
n=16 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.
|
RP2D-0825
n=43 Participants
mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.
|
RP2D-0525 (Rest Period, Day 15)
n=53 Participants
mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Febrile neutropenia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Neutropenia
|
6 Participants
|
1 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Thrombocytopenia
|
3 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Anaemia
|
5 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
ALT increased
|
2 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
AST increased
|
2 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Platelet count decreased
|
4 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Lymphopenia
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
White blood cell count decreased
|
4 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Neutrophil count decreased
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Leukopenia
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Lymphocyte count decreased
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Blood alkaline phosphatase increased
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Blood creatinine increased
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
DRESS
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Liver function test abnormal
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Bone marrow failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Haemolysis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Blood bilirubin increased
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Blood iron decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b Dose Escalation - 600 mg/600 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 600 mg/800 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 600 mg/1000 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 600 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 800 mg/1000 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 800 mg (5 Days)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 800 mg/600 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1b Dose Escalation - 800 mg/800 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b Dose Escation - 800 mg (7 Days)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 - 800 mg/800 mg
Serious events: 13 serious events
Other events: 18 other events
Deaths: 1 deaths
Phase 2 - 800 mg
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b Dose Escalation - 600 mg/600 mg
n=3 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/800 mg
n=1 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/1000 mg
n=1 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg
n=2 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
n=5 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (5 Days)
n=5 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
n=1 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
n=1 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg (7 Days)
n=3 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
|
Phase 2 - 800 mg/800 mg
n=27 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 2 - 800 mg
n=16 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Apraxia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Convulsion
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
14.8%
4/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Central nervous system necrosis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Cystitis noninfective
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Musculoskeletal and connective tissue disorders
Hemiparesis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Herpes simplex encephalitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Meningitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Respirovirus test positive
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Psychiatric disorders
Somnolence
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
Other adverse events
| Measure |
Phase 1b Dose Escalation - 600 mg/600 mg
n=3 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/800 mg
n=1 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg/1000 mg
n=1 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 600 mg
n=2 participants at risk
Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/1000 mg
n=5 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg (5 Days)
n=5 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/600 mg
n=1 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escalation - 800 mg/800 mg
n=1 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 1b Dose Escation - 800 mg (7 Days)
n=3 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.
|
Phase 2 - 800 mg/800 mg
n=27 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.
|
Phase 2 - 800 mg
n=16 participants at risk
Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
100.0%
1/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
100.0%
1/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
14.8%
4/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
66.7%
2/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
11.1%
3/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
100.0%
1/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
25.0%
4/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Apraxia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
18.8%
3/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Musculoskeletal and connective tissue disorders
Hemiparesis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
100.0%
1/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
33.3%
1/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
11.1%
3/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
7.4%
2/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
12.5%
2/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Infections and infestations
Cystitis noninfective
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
General disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Herpes simplex encephalitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Hepatobiliary disorders
Liver function abnormal
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
6.2%
1/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Meningitis
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/1 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/3 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
3.7%
1/27 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
0.00%
0/16 • Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.
Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose. For the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \>=3 criteria (which is for severity, rather than frequency).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place