Trial Outcomes & Findings for A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma (NCT NCT04434469)
NCT ID: NCT04434469
Last Updated: 2024-07-03
Results Overview
Adverse event severity graded according to NCI CTCAE v5.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Baseline up to 1 year 7 months
Results posted on
2024-07-03
Participant Flow
The study consisted of a screening period of up to 28 days and a minimum follow-up period of 90 days after treatment. Following confirmation of eligibility, patients received RO7297089 by intravenous (IV) infusion. Patients were enrolled in two stages: a dose escalation stage and an expansion stage.
Participant milestones
| Measure |
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
4
|
6
|
6
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
5
|
6
|
3
|
Reasons for withdrawal
| Measure |
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
2
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Study terminated by sponsor
|
1
|
1
|
1
|
2
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=5 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=4 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=6 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=6 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
62.6 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
54.3 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
60.2 Years
STANDARD_DEVIATION 6.3 • n=21 Participants
|
65.7 Years
STANDARD_DEVIATION 7.4 • n=10 Participants
|
61.7 Years
STANDARD_DEVIATION 7.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 1 year 7 monthsPopulation: Safety-Evaluable Patients
Adverse event severity graded according to NCI CTCAE v5.0
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=5 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=4 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=6 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=6 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
75 Percentage of Participants
|
100 Percentage of Participants
|
83.3 Percentage of Participants
|
100 Percentage of Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Cohorts reported with participants excluded from descriptive statistics due to not receiving the full dose: Cohort 2: 1 participant Cohort 3: 1 participant Cohort 4A: 2 participants Cohort 4B reported with 1 participant excluded from descriptive statistics due to apparent outlier and 1 participant due to or missing sample.
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=4 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=3 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=4 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=4 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Concentration Observed (Tmax) of RO7297089
|
0.25 EOI, day
Interval 0.08 to 0.25
|
0.17 EOI, day
Interval 0.08 to 0.25
|
0.08 EOI, day
Interval 0.08 to 0.08
|
0.25 EOI, day
Interval 0.25 to 0.25
|
1.08 EOI, day
Interval 1.08 to 1.17
|
1.08 EOI, day
Interval 1.08 to 2.11
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Only those participants who received full dose were included in the results summary
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=4 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=3 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=1 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=4 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of RO7297089
|
12.7 ug/mL*day
Standard Deviation 26.3
|
78.7 ug/mL*day
Standard Deviation 31.3
|
280 ug/mL*day
Standard Deviation 73.6
|
1347 ug/mL*day
Standard Deviation NA
Only 1 participant analyzed
|
1046 ug/mL*day
Standard Deviation 28.0
|
1920 ug/mL*day
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 2 Day 8Population: Only those participants who received full dose were included in the results summary
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=4 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=3 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=1 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=4 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Maximum Concentration Observed (Cmax) of RO7297089
C1D1
|
7.79 ug/mL
Standard Deviation 21.6
|
40.9 ug/mL
Standard Deviation 46.3
|
95.9 ug/mL
Standard Deviation 35.8
|
314 ug/mL
Standard Deviation NA
Only 1 participant analyzed
|
305 ug/mL
Standard Deviation 15.5
|
404 ug/mL
Standard Deviation 12.4
|
|
Maximum Concentration Observed (Cmax) of RO7297089
C2D8
|
9.50 ug/mL
Standard Deviation 24.1
|
48.6 ug/mL
Standard Deviation 23.6
|
153 ug/mL
Standard Deviation 47.5
|
394 ug/mL
Standard Deviation NA
Only 1 participant analyzed
|
541 ug/mL
Standard Deviation 38.9
|
966 ug/mL
Standard Deviation 24.7
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 2 Day 8Population: Only those participants who received full dose were included in the results summary
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=4 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=3 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=1 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=4 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Minimum Concentration Observed (Cmin) of RO7297089
C1D1
|
0.19 ug/mL
Standard Deviation 22.3
|
0.96 ug/mL
Standard Deviation 42.5
|
9.19 ug/mL
Standard Deviation 500
|
140 ug/mL
Standard Deviation NA
Only 1 participant analyzed
|
81.3 ug/mL
Standard Deviation 85.1
|
197 ug/mL
Standard Deviation 32.6
|
|
Minimum Concentration Observed (Cmin) of RO7297089
C2D8
|
0.25 ug/mL
Standard Deviation 39.9
|
2.99 ug/mL
Standard Deviation NA
Only 1 participant analyzed
|
19.7 ug/mL
Standard Deviation 372
|
163 ug/mL
Standard Deviation NA
Only 1 participant analyzed
|
207 ug/mL
Standard Deviation 90.0
|
450 ug/mL
Standard Deviation 40.2
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Only those participants who received full dose were included in the results summary
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=4 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=3 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=1 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=4 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Half-life (t1/2) of RO7297089
|
1.39 day
Standard Deviation 8.33
|
1.25 day
Standard Deviation 14.9
|
2.39 day
Standard Deviation 89.5
|
6.73 day
Standard Deviation NA
Only 1 participant analyzed
|
4.22 day
Standard Deviation 83.7
|
6.52 day
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Baseline up to approximately 19 monthsORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
Outcome measures
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 Participants
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=4 Participants
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=4 Participants
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=6 Participants
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=5 Participants
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 Participants
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
Progressive disease
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate (ORR)
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Objective Response Rate (ORR)
Minimal Response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Objective Response Rate (ORR)
Stable disease
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
Adverse Events
Dose Escalation Cohort 1: RO7297089
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Dose Escalation Cohort 2: RO7297089
Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths
Dose Escalation Cohort 3: RO7297089
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Escalation Cohort 4: RO7297089
Serious events: 5 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Escalation Backfill Cohort 4: RO7297089
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Dose Escalation Cohort 5: RO7297089
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 participants at risk
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=5 participants at risk
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=4 participants at risk
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=6 participants at risk
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=6 participants at risk
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 participants at risk
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
50.0%
2/4 • Number of events 5 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 2 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
60.0%
3/5 • Number of events 5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 3 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
50.0%
2/4 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
40.0%
2/5 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
Other adverse events
| Measure |
Dose Escalation Cohort 1: RO7297089
n=3 participants at risk
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 2: RO7297089
n=5 participants at risk
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 3: RO7297089
n=4 participants at risk
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Cohort 4: RO7297089
n=6 participants at risk
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
|
Dose Escalation Backfill Cohort 4: RO7297089
n=6 participants at risk
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
|
Dose Escalation Cohort 5: RO7297089
n=3 participants at risk
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
60.0%
3/5 • Number of events 3 • Baseline up to 1 year and 7 months
|
75.0%
3/4 • Number of events 5 • Baseline up to 1 year and 7 months
|
50.0%
3/6 • Number of events 4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Oedema
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
50.0%
2/4 • Number of events 2 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
60.0%
3/5 • Number of events 4 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
40.0%
2/5 • Number of events 3 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Blood phosphorus decreased
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
C-reactive protein increased
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Calcium ionised increased
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Escherichia test positive
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
33.3%
2/6 • Number of events 2 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
25.0%
1/4 • Number of events 4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
16.7%
1/6 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
20.0%
1/5 • Number of events 2 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Baseline up to 1 year and 7 months
|
0.00%
0/5 • Baseline up to 1 year and 7 months
|
0.00%
0/4 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
0.00%
0/6 • Baseline up to 1 year and 7 months
|
33.3%
1/3 • Number of events 1 • Baseline up to 1 year and 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER