Trial Outcomes & Findings for Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM (NCT NCT00648739)
NCT ID: NCT00648739
Last Updated: 2019-03-05
Results Overview
The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
From first dose through 10 weeks after the last dose
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Samalizumab 50 mg/m^2
Participants assigned to this dose cohort received a single intravenous (IV) dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
3
|
3
|
3
|
7
|
1
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
5
|
3
|
3
|
3
|
7
|
1
|
|
Overall Study
COMPLETED
|
2
|
3
|
0
|
1
|
1
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
2
|
2
|
5
|
1
|
Reasons for withdrawal
| Measure |
Samalizumab 50 mg/m^2
Participants assigned to this dose cohort received a single intravenous (IV) dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Investigator Considered it Advisable
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Positive Human Anti-human Antibody
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Follow-up Visits Not Completed
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM
Baseline characteristics by cohort
| Measure |
Samalizumab
n=26 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|
|
Age, Continuous
|
65.8629 years
STANDARD_DEVIATION 12.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Type of Malignancy
B-Cell Chronic Lymphocytic Leukemia
|
23 Participants
n=5 Participants
|
|
Type of Malignancy
Multiple Myeloma
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose through 10 weeks after the last dosePopulation: All participants who received at least 1 dose of samalizumab.
The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.
Outcome measures
| Measure |
Samalizumab
n=26 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Overall
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) Of Samalizumab
|
NA mg/m^2
The MTD was not reached. The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose through 10 weeks after the last dosePopulation: All participants who received at least 1 dose of samalizumab.
A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Samalizumab
n=4 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
n=7 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
n=1 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Overall
n=26 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|---|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Discontinued due to Adverse Events
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
At Least 1 TEAE
|
4 participants
|
5 participants
|
3 participants
|
3 participants
|
3 participants
|
6 participants
|
1 participants
|
25 participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent Serious Adverse Event
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse Events Leading to Death
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline (Predose) and Day 1 (Postdose)Population: All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.
Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
Outcome measures
| Measure |
Samalizumab
n=4 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
n=2 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
n=2 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Overall
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)
Baseline (Predose)
|
0.60 percentage of B-CLL cells bound
Interval 0.3 to 5.9
|
0.80 percentage of B-CLL cells bound
Interval 0.2 to 2.4
|
0.50 percentage of B-CLL cells bound
Interval 0.3 to 0.7
|
0.60 percentage of B-CLL cells bound
Interval 0.5 to 0.7
|
3.20 percentage of B-CLL cells bound
Interval 1.1 to 5.7
|
1.40 percentage of B-CLL cells bound
Interval 0.1 to 2.1
|
—
|
—
|
|
Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)
Day 1 (Postdose)
|
2.50 percentage of B-CLL cells bound
Interval 1.1 to 4.8
|
3.90 percentage of B-CLL cells bound
Interval 0.2 to 9.5
|
28.70 percentage of B-CLL cells bound
Interval 27.8 to 29.6
|
16.80 percentage of B-CLL cells bound
Interval 5.0 to 28.6
|
13.50 percentage of B-CLL cells bound
Interval 1.7 to 71.3
|
3.40 percentage of B-CLL cells bound
Interval 1.0 to 47.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Predose) and Day 1 (Postdose)Population: All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.
Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
Outcome measures
| Measure |
Samalizumab
n=4 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
n=2 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
n=2 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Overall
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|---|
|
Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose)
Day 1 (Postdose)
|
3.85 mean channel fluorescent intensity
Interval 3.3 to 4.1
|
7.10 mean channel fluorescent intensity
Interval 5.0 to 11.1
|
17.95 mean channel fluorescent intensity
Interval 16.6 to 19.3
|
11.20 mean channel fluorescent intensity
Interval 5.6 to 16.8
|
5.80 mean channel fluorescent intensity
Interval 4.6 to 26.6
|
2.30 mean channel fluorescent intensity
Interval 1.9 to 17.6
|
—
|
—
|
|
Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose)
Baseline (Predose)
|
2.95 mean channel fluorescent intensity
Interval 1.9 to 11.0
|
4.10 mean channel fluorescent intensity
Interval 3.5 to 5.6
|
3.25 mean channel fluorescent intensity
Interval 3.2 to 3.3
|
2.35 mean channel fluorescent intensity
Interval 1.7 to 3.0
|
2.40 mean channel fluorescent intensity
Interval 1.7 to 3.4
|
1.40 mean channel fluorescent intensity
Interval 1.0 to 3.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose through 10 weeks after the last dosePopulation: All participants with B-CLL who received at least 1 dose of samalizumab.
Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=\>50% increase for \>2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.
Outcome measures
| Measure |
Samalizumab
n=4 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
n=3 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
n=5 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Overall
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
Progressive Disease
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
Stable Disease
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
Not Evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
ORR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose through 10 weeks after the last dosePopulation: All participants with MM who received at least 1 dose of samalizumab.
Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.
Outcome measures
| Measure |
Samalizumab
n=2 Participants
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=1 Participants
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Overall
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
Progressive Disease
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
Partial Response
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
Stable Disease
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
Not Evaluable
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
ORR
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Samalizumab 50 mg/m^2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Samalizumab 100 mg/m^2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Samalizumab 200 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Samalizumab 300 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Samalizumab 400 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Samalizumab 500 mg/m^2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Samalizumab 600 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Samalizumab 50 mg/m^2
n=4 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=5 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
n=3 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
n=3 participants at risk
Participants assigned to this dose cohort received a single IV 300 mg/m\^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
n=3 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
n=7 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
n=1 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Visual acuity reduced
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
Other adverse events
| Measure |
Samalizumab 50 mg/m^2
n=4 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 100 mg/m^2
n=5 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 200 mg/m^2
n=3 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 300 mg/m^2
n=3 participants at risk
Participants assigned to this dose cohort received a single IV 300 mg/m\^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 400 mg/m^2
n=3 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 500 mg/m^2
n=7 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
Samalizumab 600 mg/m^2
n=1 participants at risk
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Eye pain
|
50.0%
2/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Night blindness
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Photophobia
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Photopsia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
28.6%
2/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
66.7%
2/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
1/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
40.0%
2/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Asthenia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
40.0%
2/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Chest pain
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Chills
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Face oedema
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Fatigue
|
50.0%
2/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
40.0%
2/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
3/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
28.6%
2/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
1/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Injection site extravasation
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
1/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Pain
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Peripheral coldness
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
40.0%
2/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Candidiasis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Infected epidermal cyst
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Pharyngitis
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
28.6%
2/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
66.7%
2/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
28.6%
2/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Injury, poisoning and procedural complications
Medication error
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Investigations
Blood viscosity increased
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Investigations
Haemoglobin
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Investigations
Platelet count
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
1/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
1/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
28.6%
2/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
100.0%
1/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
66.7%
2/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Renal and urinary disorders
Micturition urgency
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
28.6%
2/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
14.3%
1/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
40.0%
2/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
40.0%
2/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Surgical and medical procedures
Dermabrasion
|
25.0%
1/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
33.3%
1/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
20.0%
1/5 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/3 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/7 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
0.00%
0/1 • From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place