Trial Outcomes & Findings for Dose Finding Safety Study of VAL201 in Cancer Patients (NCT NCT02280317)
NCT ID: NCT02280317
Last Updated: 2021-11-08
Results Overview
The number of Dose-Limiting Toxicity events is used to determine whether a maximum tolerated dose (MTD) is obtained.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
The average timeframe is 18-26 weeks per subject
Results posted on
2021-11-08
Participant Flow
The study will enrol patients with locally advanced or metastatic prostate cancer. The MTD/MAD may also be evaluated in patients with other advanced tumour types for whom no standard effective therapy is available and a rationale for use of VAL201 exists.
Interventional Study Model; Sequential Assignment -Dose Escalation sequential assignment-
Participant milestones
| Measure |
Cohort 1: 0.5 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 0.5mg/kg.
|
Cohort 2: 1.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg
|
Cohort 4: 4.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg
|
Cohort 5: Up to 8.0 mg/kg
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
5
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Finding Safety Study of VAL201 in Cancer Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: 0.5 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2 mg/kg
n=3 Participants
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4 mg/kg
n=5 Participants
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg
n=2 Participants
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
62 years
n=7 Participants
|
76 years
n=5 Participants
|
72.6 years
n=4 Participants
|
73 years
n=21 Participants
|
72.4 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=8 Participants
|
|
Stage of Cancer at Screening
Metastatic Prostate Cancer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Stage of Cancer at Screening
Locally Advanced Prostate Cancer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: The average timeframe is 18-26 weeks per subjectThe number of Dose-Limiting Toxicity events is used to determine whether a maximum tolerated dose (MTD) is obtained.
Outcome measures
| Measure |
Cohort 1: 0.5 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
n=3 Participants
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
n=5 Participants
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg
n=2 Participants
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
|---|---|---|---|---|---|
|
Dose-Limiting Toxicity
Dose-limiting Toxicity observed (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Dose-Limiting Toxicity
Dose-reduction required
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose-Limiting Toxicity
MTD or MAD proposed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The average timeframe is 18-26 weeks per subjectPopulation: Cohort 5 consisted of one participant dosed at 8 mg/kg and one participant dosed at 4 mg/kg, on which pharmacokinetic parameters were measured; pharmacokinetic data was not analysed for Cohorts 1-4. Pharmacokinetic profiles were collected on multiple dosing days.
Assessment of pharmacokinetic variables at multiple time points (5 min, 10 min, 15 min, 30 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after dosing) and multiple dosing days (Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 6 Day 1) for each patient analysed.
Outcome measures
| Measure |
Cohort 1: 0.5 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
|---|---|---|---|---|---|
|
Pharmacokinetics of VAL201. (Cmax)
|
3323 ng/mL
Interval 2522.0 to 4232.0
|
2205 ng/mL
Interval 1448.0 to 2765.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The average timeframe is 18-26 weeks per subjectPopulation: Cohort 5 consisted of one participant dosed at 8 mg/kg and one participant dosed at 4 mg/kg, on which pharmacokinetic parameters were measured; pharmacokinetic data was not analysed for Cohorts 1-4. Pharmacokinetic profiles were collected on multiple dosing days.
Assessment of pharmacokinetic variables at multiple time points (5 min, 10 min, 15 min, 30 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after dosing) and multiple dosing days (Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 6 Day 1) for each patient analysed.
Outcome measures
| Measure |
Cohort 1: 0.5 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
|---|---|---|---|---|---|
|
Pharmacokinetics of VAL201 (AUC 0-inf)
|
5.0 ug/mL*h
Interval 4.78 to 5.28
|
3.8 ug/mL*h
Interval 2.36 to 4.51
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The average timeframe is 18-26 weeks per subjectThe number of patients who completed 6 cycles of treatment is compared with the number who withdrew prior to completion of the scheduled 6 cycles
Outcome measures
| Measure |
Cohort 1: 0.5 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
n=3 Participants
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
n=5 Participants
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg
n=2 Participants
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
|---|---|---|---|---|---|
|
Number of Patients Who Completed 6 Cycles of Treatment
Completed 6 cycles of treatment
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients Who Completed 6 Cycles of Treatment
Withdrew from trial prior to completion
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The average timeframe is 18-26 weeks per subjectPopulation: Excludes one participant from Cohort 4 who received a single dose
Assessment of disease response to treatment by PCWG2 and/or RECIST. Disease progression is defined by RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; and by PCWG2 criteria that PSA values did not see an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir.
Outcome measures
| Measure |
Cohort 1: 0.5 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 Participants
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
n=3 Participants
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
n=4 Participants
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg
n=2 Participants
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
|
|---|---|---|---|---|---|
|
Number of Patients Displaying Disease Progression by PCWG2 and/or RECIST Criteria
Showed no progressive disease during trial period according to PCWG2
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients Displaying Disease Progression by PCWG2 and/or RECIST Criteria
Showed progressive disease at any point during trial period according to PCWG2
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort 1: 0.5 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: 1.0 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: 2.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4: 4.0 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5: up to 8 mg/kg (8 mg/kg)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: up to 8 mg/kg (4 mg/kg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 0.5 mg/kg
n=1 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
n=3 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
n=5 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg (8 mg/kg)
n=1 participants at risk
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
This patient received 8 mg/kg
|
Cohort 5: up to 8 mg/kg (4 mg/kg)
n=1 participants at risk
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
This patient received 4 mg/kg
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
Other adverse events
| Measure |
Cohort 1: 0.5 mg/kg
n=1 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 0.5 mg/kg.
|
Cohort 2: 1.0 mg/kg
n=1 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 1.0 mg/kg.
|
Cohort 3: 2.0 mg/kg
n=3 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 2.0 mg/kg.
|
Cohort 4: 4.0 mg/kg
n=5 participants at risk
VAL201: VAL201-001 Sub-cutaneous injection 4.0 mg/kg.
|
Cohort 5: up to 8 mg/kg (8 mg/kg)
n=1 participants at risk
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
This patient received 8 mg/kg
|
Cohort 5: up to 8 mg/kg (4 mg/kg)
n=1 participants at risk
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
This patient received 4 mg/kg
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Vascular disorders
Hot Flushes
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
3/3 • Number of events 3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
60.0%
3/5 • Number of events 3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Injection site rash
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
80.0%
4/5 • Number of events 4 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Injection site reaction
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
66.7%
2/3 • Number of events 2 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Injection site pain
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
40.0%
2/5 • Number of events 2 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Injection site erythema
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Chills
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Injection site brusing
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Injection site pruritus
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Skin and subcutaneous tissue disorders
Epistaxis
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
40.0%
2/5 • Number of events 2 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Dyspepsia
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
60.0%
3/5 • Number of events 3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Dental caries
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Renal and urinary disorders
Nocturia
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Renal and urinary disorders
Pelvic pain
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
33.3%
1/3 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Upper respiratory tract infection
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
20.0%
1/5 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/3 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/5 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
0.00%
0/1 • 18 weeks.
All events experienced by patients recorded here, regardless of assessment of causality as related or not to drug treatment. Cohort 5 has been segregated into Cohort 5 (8 mg/kg) and Cohort 5 (4 mg/kg) to delineate the actual dose given in this group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee "There is an agreement in place with the PI and the sponsor that restricts the PI's rights to discuss and publish the trial results after the trial is completed".
- Publication restrictions are in place
Restriction type: OTHER