Trial Outcomes & Findings for MEK and MET Inhibition in Colorectal Cancer (NCT NCT02510001)
NCT ID: NCT02510001
Last Updated: 2021-07-13
Results Overview
Determine maximum tolerated dose (MTD) of PD-0325901 with Crizotinib (PF-02341066) according to toxicities graded by NCI CTCAE v4.03, in patients with advanced solid tumours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
Dose Escalation Phase: treatment Cycle 1 28 days (plus 7 day run-in for PD-0325901/PF-02341066 combination)
Results posted on
2021-07-13
Participant Flow
1 patient in escalation phase dose 5 was registered to the trial on 28Sep2016 but withdrew before dose administration due to unexpected and fast disease progression.
Participant milestones
| Measure |
Dose Escalation Phase Dose 1.
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Dose 2.
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Dose 3.
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Dose 4.
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. Crizotinib (PF-02341066) 250mg OD continuous administration
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
6
|
8
|
8
|
7
|
5
|
37
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
4
|
5
|
3
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
4
|
2
|
2
|
7
|
Reasons for withdrawal
| Measure |
Dose Escalation Phase Dose 1.
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Dose 2.
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Dose 3.
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Dose 4.
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. Crizotinib (PF-02341066) 250mg OD continuous administration
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. Crizotinib (PF-02341066) 200mg BD continuous administration
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Early disease progression
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
5
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase Dose 1.
n=6 Participants
Crizotinib 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.
|
Dose Escalation Phase Dose 2.
n=5 Participants
Crizotinib 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.
|
Dose Escalation Phase Dose 3.
n=6 Participants
Crizotinib 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day 1, then Day 1-21 every 28 day cycle
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.
|
Dose Escalation Phase Dose 4.
n=8 Participants
Crizotinib 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day1, then Day 1-21 every 28 day cycle
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.
|
Dose Escalation Phase 5.
n=8 Participants
Binimetinib 30mg BD continuous administration or Days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
PD-0325901: PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5a
n=7 Participants
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
n=37 Participants
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
n=5 Participants
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=37 Participants
|
4 Participants
n=5 Participants
|
56 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=37 Participants
|
1 Participants
n=5 Participants
|
26 Participants
n=82 Participants
|
|
Age, Continuous
|
65.8 years
n=6 Participants
|
64.8 years
n=5 Participants
|
58.4 years
n=6 Participants
|
61.2 years
n=8 Participants
|
51.0 years
n=8 Participants
|
60.0 years
n=7 Participants
|
62.0 years
n=37 Participants
|
55.0 years
n=5 Participants
|
60.4 years
n=82 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=37 Participants
|
3 Participants
n=5 Participants
|
36 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=37 Participants
|
2 Participants
n=5 Participants
|
46 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Dose Escalation Phase: treatment Cycle 1 28 days (plus 7 day run-in for PD-0325901/PF-02341066 combination)Population: Evaluable patients are those patients who completed cycle 1 or withdrew early for experiencing a DLT. Four patients withdrew early from the study not for DLTs, consequently 21 patients remained for the dose escalation primary analysis.
Determine maximum tolerated dose (MTD) of PD-0325901 with Crizotinib (PF-02341066) according to toxicities graded by NCI CTCAE v4.03, in patients with advanced solid tumours.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=6 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Maximal Tolerated Dose (MTD) of PD-0325901 and PF-02341066 /PF-02341066 or Binimetinib With PF-02341066
|
0 Dose Limiting Toxicities (DLTs)
|
0 Dose Limiting Toxicities (DLTs)
|
0 Dose Limiting Toxicities (DLTs)
|
1 Dose Limiting Toxicities (DLTs)
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Dose Expansion phase: change from baseline and up to 12 months.Population: Evaluable patients for the primary outcome are those patients who complete a response assessment after cycle 1 of treatment, or who progress early on treatment. 30 of the 36 recruited patients had a response assessment after cycle 1 or progressed early on treatment, and hence these 30 patients are evaluable for the primary analysis.
To investigate response to treatment with RPII dose of Binimetinib with Crizotinib (PF-02341066), in patients with a) RASMT CRC or b) RASWT/cMET mut amplified CRC or c) RASWT/c-MET over-expressed CRC, as defined by stable, partially or completely responding disease, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase (\>=20%) to qualify for Progressive Disease; Overall Response (OR) = CR + PR + SD
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=30 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Response to Binimetinib Combined With PF-02341066
Stable Disease
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Response to Binimetinib Combined With PF-02341066
Progressive Disease
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Response to Binimetinib Combined With PF-02341066
Early death from malignant disease
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Dose Escalation Phase: treatment Cycle 1 28 daysPopulation: Evaluable patients are those patients who completed cycle 1 or who withdraw early for experiencing a DLT. Three patients withdrew early from the study not for DLTs, consequently 17 of the 20 recruited patients are evaluable for this analysis.
To determine the maximal tolerated dose (MTD) of Binimetinib with PF-02341066 according to toxicities graded by NCI CTCAE V4.03 in cycle 1 of treatment.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=6 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Maximal Tolerated Dose (MTD) of Binimetinib and PF-02341066
|
2 Dose Limiting Toxicities (DLTs)
|
2 Dose Limiting Toxicities (DLTs)
|
1 Dose Limiting Toxicities (DLTs)
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation:Up to 12 months. PK profile at pre-dose and up to 10 hrs post dose on Day - 1, Day 21 and Day 28 of Cycle 1To investigate the pharmacokinetics (PK) plasma Cmax of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901.
Summary PD-0325901 PK Day -1
|
77.8 ng/ml
Standard Deviation 41.9
|
129 ng/ml
Standard Deviation 50.5
|
226 ng/ml
Standard Deviation 66.1
|
484 ng/ml
Standard Deviation 84.1
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901.
Summary PD-0325901 PK Day 21
|
70.3 ng/ml
Standard Deviation 43.1
|
62.3 ng/ml
Standard Deviation 34.7
|
135 ng/ml
Standard Deviation 36.2
|
219 ng/ml
Standard Deviation 93.6
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901.
Summary PD-0315209 PK Day -1
|
53.1 ng/ml
Standard Deviation 30.7
|
59.4 ng/ml
Standard Deviation 35.3
|
117 ng/ml
Standard Deviation 44.3
|
195 ng/ml
Standard Deviation 55.6
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901.
Summary PD-0315209 PK Day 21
|
52.0 ng/ml
Standard Deviation 24.8
|
46.7 ng/ml
Standard Deviation 29.5
|
103 ng/ml
Standard Deviation 40.5
|
117 ng/ml
Standard Deviation 57.6
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901.
Summary PF-02341066 PK Day 21
|
170 ng/ml
Standard Deviation 81.3
|
300 ng/ml
Standard Deviation 53.9
|
235 ng/ml
Standard Deviation 35.3
|
269 ng/ml
Standard Deviation 157
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901.
Summary PF-02341066 PK Day 28
|
164 ng/ml
Standard Deviation 59.8
|
281 ng/ml
Standard Deviation 118
|
341 ng/ml
Standard Deviation 133
|
275 ng/ml
Standard Deviation 105
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation:Up to 12 mths. Cycle 1 PK profile up to 10 hrs post dose on Day -1, 21 and 28Population: PK analysis performed on Cycle 1 Day -1 and Day 21 only for PD-0325901 and PD-0315209 and on Cycle 1 Day 21 and Day 28 only for PF-02341066 according to dosing schedule Day -7 to Day 21 for PD-0325901 and Day 1 to Day 28 for PF-02341066.
To investigate the pharmacokinetics (PK) plasma Cmin of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901
Summary PD-0325901 PK Day -1
|
23.6 ng/ml
Standard Deviation 9.3
|
18.7 ng/ml
Standard Deviation 5.83
|
37.9 ng/ml
Standard Deviation 5.89
|
89.2 ng/ml
Standard Deviation 24.3
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901
Summary PD-0325901 PK Day 21
|
26.0 ng/ml
Standard Deviation 16.1
|
17.6 ng/ml
Standard Deviation 3.12
|
35.8 ng/ml
Standard Deviation 13.3
|
45.4 ng/ml
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901
Summary PD-0315209 PK Day -1
|
44.0 ng/ml
Standard Deviation 29.6
|
40.4 ng/ml
Standard Deviation 26.3
|
80.6 ng/ml
Standard Deviation 22.1
|
147 ng/ml
Standard Deviation 47.7
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901
Summary PD-0315209 PK Day 21
|
41.3 ng/ml
Standard Deviation 23.3
|
37.3 ng/ml
Standard Deviation 25.4
|
66.6 ng/ml
Standard Deviation 18.8
|
73.1 ng/ml
Standard Deviation 31.7
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901
Summary PF-02341066 PK Day 21
|
115 ng/ml
Standard Deviation 64.4
|
186 ng/ml
Standard Deviation 55.8
|
172 ng/ml
Standard Deviation 43.6
|
203 ng/ml
Standard Deviation 121
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901
Summary PF-02341066 PK Day 28
|
119 ng/ml
Standard Deviation 44.4
|
183 ng/ml
Standard Deviation 66.3
|
259 ng/ml
Standard Deviation 96.0
|
211 ng/ml
Standard Deviation 78.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation:Up to12 months. Cycle 1 PK profile up to 10 hrs on Day -1, 21 and 28Population: PK analysis performed on Cycle 1 Day -1 and Day 21 only for PD-0325901 and PD-0315209 and on Cycle 1 Day 21 and Day 28 only for PF-02341066 according to dosing schedule Day -7 to Day 21 for PD-0325901 and Day 1 to Day 28 for PF-02341066.
To investigate the pharmacokinetics (PK) plasma AUC of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite)
Summary PD-0325901 PK Day -1
|
400 ng*hr/mL
Standard Deviation 117
|
432 ng*hr/mL
Standard Deviation 129
|
796 ng*hr/mL
Standard Deviation 120
|
1907 ng*hr/mL
Standard Deviation 254
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite)
Summary PD-0325901 PK Day 21
|
400 ng*hr/mL
Standard Deviation 160
|
301 ng*hr/mL
Standard Deviation 106
|
683 ng*hr/mL
Standard Deviation 51.7
|
1162 ng*hr/mL
Standard Deviation 190
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite)
Summary PD-0315209 PK Day -1
|
498 ng*hr/mL
Standard Deviation 304
|
508 ng*hr/mL
Standard Deviation 318
|
954 ng*hr/mL
Standard Deviation 301
|
1726 ng*hr/mL
Standard Deviation 501
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite)
Summary PD-0315209 PK Day 21
|
487 ng*hr/mL
Standard Deviation 226
|
413 ng*hr/mL
Standard Deviation 273
|
831 ng*hr/mL
Standard Deviation 246
|
1092 ng*hr/mL
Standard Deviation 228
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite)
Summary PF-02341066 PK Day 21
|
1341 ng*hr/mL
Standard Deviation 688
|
2115 ng*hr/mL
Standard Deviation 448
|
2034 ng*hr/mL
Standard Deviation 397
|
2336 ng*hr/mL
Standard Deviation 1414
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite)
Summary PF-02341066 PK Day 28
|
1378 ng*hr/mL
Standard Deviation 567
|
2358 ng*hr/mL
Standard Deviation 905
|
2919 ng*hr/mL
Standard Deviation 1207
|
2402 ng*hr/mL
Standard Deviation 873
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation:Up to12 months.PK profile at Cycle 1 up to 10 hrs post dose on Days -1, 21 and 28Population: Oral clearance could not be calculated, as pre-specified, as bioavailability and full Area Under the Curve (AUC) data, specifically 0 to ∞ (infinity), was not available. Even though AUC data is available on Days -1, 21 and 28 for 0-10 hours, residual drug at time of next twice daily dose administration meant oral clearance could not be determined for most patients.
To investigate the pharmacokinetics (PK) plasma oral clearance of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of study entry until the date of progression or date of death, assessed up to study completion, an average of 6 months (dose expansion)).Population: All 37 registered patients are included in this analysis.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions (also demonstrating an absolute increase of at least 5mm) or the appearance of new lesions.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=37 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (Dose Expansion)
|
1.81 months
Interval 1.51 to 1.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of study entry until the date of death, assessed up to study completion, an average of 6 months (dose escalation).Population: All 37 registered patients are included in this analysis.
Overall survival (dose expansion).
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=37 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (Dose Expansion)
|
5.42 months
Interval 2.79 to 7.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: PK profile up to 10 hrs at Cycle 1 Day 21Population: Data not available for 2 patients in PF-02341066 outcome measure and 8 patients each in binimetinib and AR00426032 outcome measures
To investigate the pharmacokinetic (PK) peak plasma concentration (Cmax) of PF-02341066 and Binimetinib and its metabolite, AR00426032, in blood.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=26 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib.
Summary PF-02341066 PK Cycle 1 D21 up to 10h
|
197 ng/ml
Standard Deviation 112
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib.
Summary binimetinib PK Cycle 1 D21 up to 10h
|
357 ng/ml
Standard Deviation 171
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib.
Summary AR00426032 PK Cycle 1 D21
|
22.7 ng/ml
Standard Deviation 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: PK profile on Cycle 1 Day 21 up to 10 hrs .Population: No data available for 8 patients for binimetinib outcome and for 16 patients in AR00426032 outcome measure.
To investigate pharmacokinetic plasma trough concentration Cmin of PF-02341066 and Binimetinib and its metabolite, AR00426032, in blood.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=26 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib.
Summary PF-02341066 PK Cycle 1 D21 up to 10h
|
149 Cmin (ng/ml)
Standard Deviation 85.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib.
Summary binimetinib PK Cycle 1 D21 up to 10h
|
103 Cmin (ng/ml)
Standard Deviation 58.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib.
Summary AR00426032 PK Cycle 1 D21
|
12.1 Cmin (ng/ml)
Standard Deviation 4.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: PK profile on Cycle 1 Day 21 up to 10 hrsPopulation: No data available for 2 patients in PF-02341066 outcome measure, 8 for binimetinib outcome measure and 13 for AR00426032 outcome measure
To investigate pharmacokinetic area under the plasma concentration versus time curve (AUC) of PF-02341066 and Binimetinib in blood.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=26 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib.
Summary PF-02341066 PK Cycle 1 D21 up to 10h
|
3478 ng.h/ml (0-10h )
Standard Deviation 2083
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib.
Summary binimetinib PK Cycle 1 D21 up to 10h
|
2129 ng.h/ml (0-10h )
Standard Deviation 1152
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib.
Summary AR00426032 PK Cycle 1 D21
|
194 ng.h/ml (0-10h )
Standard Deviation 85.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation: PK profile at up to 10 hrs post dose on Cycle 1 Day 21Population: Oral clearance could not be calculated, as pre-specified, as bioavailability and full Area Under the Curve (AUC) data, specifically 0 to ∞ (infinity), was not available. Even though AUC data is available on Day 21 for 0-10 hours, residual drug at time of next twice daily dose administration meant oral clearance could not be determined for most patients.
To investigate pharmacokinetic (PK) oral clearance of PF-02341066 and Binimetinib in blood.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Dose Escalation and Expansion: at baseline and Cycle1, D15.Population: For the Dose Escalation phases of the study the paired skin biopsies were collected and analysed for eligible patients (achieving end of Cycle 1) where available. Samples for Collection of paired skin biopsies were mandatory for first 10 patients registered to the expansion phase of the study only. An additional 3 samples were collected and analysed in the Expansion phase due to multiple screening performed over several participating sites.
Measurement of phosphoMEK1/2 in skin biopsies to investigate the pharmacodynamic (PD) effect of PF-02341066 in combination with PD-0325901 or Binimetinib in paired skin biopsies to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
n=5 Participants
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
n=5 Participants
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
n=3 Participants
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
n=13 Participants
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of PF-02341066 in Combination With PD-0325901 or Binimetinib in Paired Skin Biopsies - Measurement of phosphoMEK1/2.
|
3.74 ratio
Standard Deviation 2.366
|
1.89 ratio
Standard Deviation 1.425
|
6.52 ratio
Standard Deviation 5.982
|
5.74 ratio
Standard Deviation 3.067
|
1.93 ratio
Standard Deviation 0.844
|
1.03 ratio
Standard Deviation 0.28
|
0.93 ratio
Standard Deviation 0.418
|
1.11 ratio
Standard Deviation 0.697
|
SECONDARY outcome
Timeframe: Dose Escalation: Biopsies at baseline and Cycle1 D15 - both optional.Population: Biopsies optional for this phase and only consented to by 2 patients for the combination of PF-02341066 with Binimetinib.
Measurement of pSTAT3Y705 to investigate the pharmacodynamic (PD) effect of PF-02341066 in combination with PD-0325901 or Binimetinib in paired tumour biopsies to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=2 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of PF-02341066 in Combination With PD-0325901 or Binimetinib in Paired Tumour Biopsies (Where Possible).
|
0.35 ratio
Standard Deviation 0.2687
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion: Biopsies at baseline and Cycle1 D15. Optional metastic tumour biopsy within 28 days following radiological confirmation of disease progression.Population: Most patients in expansion phase did not have biopsy collection at Day 15 despite consenting to this procedure prior to commencement of the trial mainly for ethical reasons or inability to access suitable tumour biopsy site.
Measurement of phosphoERK1/2 to investigate the pharmacodynamic (PD) effect of PF-02341066 in combination with Binimetinib in paired tumour biopsies (where possible) to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=2 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of PF-02341066 in Combination With Binimetinib in Paired Tumour Biopsies (Where Possible).
|
0.155 ratio
Standard Deviation 0.0212
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of study entry until the date of progression or date of death, assessed up to study completion, an average of 6 monthsPopulation: All patients registered for this escalation phase are included in this Intention to Treat analysis, as the number of patients in each arm are separately too small for survival analysis, and it is only to preliminarily assess efficacy of the drug. The data is presented as pre-specified in the Statistical Analysis Plan Version 1.0\_09Jun2016.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions (also demonstrating an absolute increase of at least 5mm) or the appearance of new lesions.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=20 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (Dose Escalation Binimetinib/PF-02341066).
|
2.3 months
Interval 1.78 to 5.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of study entry until the date of death, assessed up to study completion, an average of 6 monthsPopulation: All patients registered for this escalation phase are included in this Intention to Treat analysis, as the number of patients in each arm are separately too small for survival analysis, and it is only to preliminarily assess efficacy of the drug. The data is present as pre-specified in the Statistical Analysis Plan Version 1.0\_09June2016.
Overall survival (Dose escalation Binimetinib/PF-02341066).
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=20 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (Dose Escalation Binimetinib/PF-02341066)
|
8.78 months
Interval 5.16 to 14.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation:Up to 12 months. PK profile at pre-dose and up to 10 hrs post dose on Day 21 of Cycle 1Population: Dose Escalation phase using binimetinib with PF-02341066. Sample data not available in each outcome measure for 2 patients in Dose level 5 and 1 in Dose level 5 (interval dosing) .
To investigate the pharmacokinetics (PK) plasma Cmax of Binimetinib (and its metabolite AR00426032) with PF-023241066 when administered in combination.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=5 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=6 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib.
Summary PF-02341066 PK Cycle 1 D21 up to 10h
|
273 ng/ml
Standard Deviation 118
|
250 ng/ml
Standard Deviation 145
|
186 ng/ml
Standard Deviation 36.8
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib.
Summary binimetinib PK Cycle 1 D21 up to 10h
|
265 ng/ml
Standard Deviation 83.4
|
386 ng/ml
Standard Deviation 189
|
320 ng/ml
Standard Deviation 136
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib.
Summary AR00426032 PK Cycle 1 D21
|
25.1 ng/ml
Standard Deviation 15.1
|
29.5 ng/ml
Standard Deviation 8.62
|
23.4 ng/ml
Standard Deviation 8.04
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation phase :Up to 12 months. PK profile at pre-dose and up to 10 hrs post dose on Day 21 of Cycle 1Population: No data available for 4 patients in dose level 5, for 2 patients in dose level 5 (interval dosing) and for 1 patient in dose level 5a
To investigate the pharmacokinetic (PK) minimum plasma trough concentration (Cmin) of PF-02341066 and binimetinib in blood.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=3 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib.
Summary AR00426032 PK Cycle 1 D21
|
10.4 ng/ml
Standard Deviation 2.66
|
10.2 ng/ml
Standard Deviation 2.47
|
6.95 ng/ml
Standard Deviation 1.60
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib.
Summary PF-02341066 PK Cycle 1 D21 up to 10h
|
205 ng/ml
Standard Deviation 78.0
|
181 ng/ml
Standard Deviation 136
|
114 ng/ml
Standard Deviation 43.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib.
Summary binimetinib PK Cycle 1 D21 up to 10h
|
77.1 ng/ml
Standard Deviation 40.3
|
85.8 ng/ml
Standard Deviation 51.9
|
64.0 ng/ml
Standard Deviation 28.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation :Up to 12 months. PK profile pre-dose and up to 10 hrs post dose on Day 21 of Cycle 1Population: No data available for dose level 5 for 3 patients and for 2 patients in dose level 5 (interval dosing)
To investigate the pharmacokinetic (PK) area under the plasma concentration versus time curve (AUC) of PF-02341066 and Binimetinib in blood.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=4 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=6 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib.
Summary PF-02341066 PK Cycle 1 D21 up to 10h
|
2481 ng.h/ml (0-10h )
Standard Deviation 980
|
2119 ng.h/ml (0-10h )
Standard Deviation 1341
|
1467 ng.h/ml (0-10h )
Standard Deviation 410
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib.
Summary binimetinib PK Cycle 1 D21 up to 10h
|
1604 ng.h/ml (0-10h )
Standard Deviation 554
|
1780 ng.h/ml (0-10h )
Standard Deviation 706
|
1402 ng.h/ml (0-10h )
Standard Deviation 666
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib.
Summary AR00426032 PK Cycle 1 D21
|
203 ng.h/ml (0-10h )
Standard Deviation 112
|
183 ng.h/ml (0-10h )
Standard Deviation 24.8
|
121 ng.h/ml (0-10h )
Standard Deviation 28.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion phase at Cycle 1 Day 21 up to 10 hours binimetinib and its metabolite, AR00426032, and up to 24 hours for PF-02341066Population: Oral clearance could not be calculated, as pre-specified, as bioavailability and full Area Under the Curve (AUC) data, specifically 0 to ∞ (infinity), was not available. Even though AUC data is available on Day 21 for 0-10 hours, residual drug at time of next twice daily dose administration meant oral clearance could not be determined for most patients.
To investigate the pharmacokinetics (PK) plasma oral clearance of binimetinib (and its metabolite,AR00426032 ) with PF-023241066 when administered in combination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Dose Escalation and Expansion: at baseline and Cycle1, D15.Population: For the Dose Escalation phases of the study the paired skin biopsies were collected and analysed for eligible patients (achieving end of Cycle 1) where available. Samples for Collection of paired skin biopsies were mandatory for first 10 patients registered to the expansion phase of the study only. An additional 3 samples were collected and analysed in the Expansion phase due to multiple screening performed over several participating sites.
Measurement of phosphoERK1/2 to investigte the pharmacodynamic (PD) effect of PF-02341066 in combination with PD-0325901 or Binimetinib in paired skin biopsies to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
n=5 Participants
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
n=5 Participants
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
n=3 Participants
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
n=13 Participants
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of PF-02341066 in Combination With PD-0325901 or Binimetinib in Paired Skin Biopsies - Measurement of phosphoERK1/2.
|
0.47 ratio
Standard Deviation 0.277
|
0.35 ratio
Standard Deviation 0.356
|
0.49 ratio
Standard Deviation 0.727
|
0.34 ratio
Standard Deviation 0.218
|
0.38 ratio
Standard Deviation 0.238
|
0.69 ratio
Standard Deviation 0.147
|
0.23 ratio
Standard Deviation 0.166
|
0.44 ratio
Standard Deviation 0.309
|
SECONDARY outcome
Timeframe: Dose Escalation:Up to12 months.PK profile at Cycle 1 up to 10 hrs post dose on Days -1, 21 and 28Population: PK analysis performed on Cycle 1 Day -1 and Day 21 only for PD-0325901 and PD-0315209 and on Cycle 1 Day 21 and Day 28 only for PF-02341066 according to dosing schedule Day -7 to Day 21 for PD-0325901 and Day 1 to Day 28 for PF-02341066.
To investigate the pharmacokinetics (PK) plasma half life of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=6 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
n=4 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and PD-0325901
Summary Half Life of PD-0325901 PK Day -1
|
7.9 h
Standard Deviation 4.1
|
16.8 h
Standard Deviation 13.9
|
9.9 h
Standard Deviation 3.2
|
15.1 h
Standard Deviation 12.5
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and PD-0325901
Summary Half Life of PD-0325901 PK Day 21
|
4.5 h
Standard Deviation 0.7
|
9.7 h
Standard Deviation 2.8
|
6.3 h
Standard Deviation 3.2
|
24.8 h
Standard Deviation 27.9
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and PD-0325901
Summary Half Life of PD-0315209 PK Day -1
|
18.0 h
Standard Deviation 5.66
|
11.3 h
Standard Deviation 1.2
|
16.0 h
Standard Deviation 6.2
|
15.0 h
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and PD-0325901
Summary Half Life of PD-0315209 PK Day 21
|
10.6 h
Standard Deviation 4.88
|
19.3 h
Standard Deviation 3.8
|
11.0 h
Standard Deviation 1.4
|
6.6 h
Standard Deviation 0.6
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and PD-0325901
Summary Half Life of PF-02341066 PK Day 21
|
31.5 h
Standard Deviation 22.4
|
10.0 h
Standard Deviation 3.0
|
20.0 h
Standard Deviation 12.3
|
16.0 h
Standard Deviation 10.0
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and PD-0325901
Summary Half Life of PF-02341066 PK Day 28
|
31.2 h
Standard Deviation 16.3
|
12.0 h
Standard Deviation 3.3
|
18.5 h
Standard Deviation 12.0
|
22.0 h
Standard Deviation 13.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Escalation: PK profile at up to 10 hrs post dose on Cycle 1 Day 21Population: No data available for Half Life for Dose Escalation phase outcome measure for PF-02341066 due to limitations of limited time-points available and missing samples, minimal clearance over the 10hr. No data available for 3 patients in dose level 5 and 2 in dose level 5 (interval dosing) and 1 in dose level 5a.
To investigate pharmacokinetic (PK) t1/2 of PF-02341066 and Binimetinib in blood.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=4 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
n=3 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
n=5 Participants
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Plasma t1/2 for PF-02341066 and Binimetinib.
Summary Half Life for Binimetinib for PK Day 21 up to 10h
|
4.3 h
Standard Deviation 1.7
|
5.5 h
Standard Deviation 2.9
|
4.7 h
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 for PF-02341066 and Binimetinib.
Summary Half Life for AR00426032 (binimetinib metabolite) for PK Day 21 up to 10h
|
4.3 h
Standard Deviation 1.9
|
5.3 h
Standard Deviation 2.2
|
5.4 h
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Dose Expansion phase at Cycle 1 Day 21 up to 10 hours binimetinib and its metabolite, AR00426032, and up to 24 hours for PF-02341066Population: Data not available for 8 patients in PF-02341066 outcome measure, 11 patients in binimetinib outcome measure and 16 patients in AR00426032 outcome measure. Data for PF-02341066 taken at 24 hour time point due to once daily dosing.
To investigate the pharmacokinetics (PK) plasma half life of binimetinib (and its metabolite,AR00426032 ) with PF-023241066 when administered in combination.
Outcome measures
| Measure |
Dose Escalation Phase Cohort 1 Dose Level 1
n=26 Participants
Crizotinib (PF-02341066) 250mg OD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 2 Dose Level 2
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 2mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 3 Dose Level 3
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 4mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase Cohort 4 Dose Level 4
Crizotinib (PF-02341066) 200mg BD Days 1-28 continuously PD-0325901 8mg BD Run in Day -7 to Cycle 1 Day -1, then Day 1-21 every 28 day cycle
|
Dose Escalation Phase 5.
Binimetinib 30mg BD continuous administration. PF-02341066 200mg BD continuous administration
|
Dose Escalation Phase Dose 5a
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days. PF-02341066 250mg OD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Escalation Phase Dose 5 (Interval Dosing)
Binimetinib 30mg BD interval dose administration days 1-21 every 28 days. PF-02341066 200mg BD continuous administration
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
Dose Expansion Phase
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
PF-02341066: PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
Binimetinib: Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and Binimetinib
Summary t1/2 life for PF-02341066 PK Cycle 1 D21 up to 24 h
|
21 h
Standard Deviation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and Binimetinib
Summary t1/2 life for binimetinib PK Cycle 1 D21 up to 10h
|
6.32 h
Standard Deviation 8.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Plasma t1/2 Etc for PF-02341066 and Binimetinib
Summary t1/2 life for AR00426032 PK Cycle 1 D21 up to 10 hr
|
4.70 h
Standard Deviation 1.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation Phase 1 PF-02341066 and PD-0325901
Serious events: 9 serious events
Other events: 25 other events
Deaths: 18 deaths
Dose Escalation Phase 2 PF-0341066 and Binimetinib
Serious events: 12 serious events
Other events: 20 other events
Deaths: 15 deaths
Dose Expansion Phase
Serious events: 18 serious events
Other events: 36 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Dose Escalation Phase 1 PF-02341066 and PD-0325901
n=25 participants at risk
Dose Escalation Phase 1 - Crizotinib and PD-0325901
|
Dose Escalation Phase 2 PF-0341066 and Binimetinib
n=20 participants at risk
Dose Escalation Phase 2 - Binimetinib and PF-02341066
|
Dose Expansion Phase
n=36 participants at risk
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
|
|---|---|---|---|
|
Infections and infestations
Abdominal Infection
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Ascitis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Metastases
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Caridac Failure
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Central Serous Retinopathy (Bilateral)
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Cytolysis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema Face
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Fever
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Hepatobiliary disorders
Hypertransaminasemia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Mucositis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis Of Jaw
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Postural hypotension
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Postoperative Hemorrhage
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Tingling In Lower Limbs
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Worsening Back Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Wound Infection
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
Other adverse events
| Measure |
Dose Escalation Phase 1 PF-02341066 and PD-0325901
n=25 participants at risk
Dose Escalation Phase 1 - Crizotinib and PD-0325901
|
Dose Escalation Phase 2 PF-0341066 and Binimetinib
n=20 participants at risk
Dose Escalation Phase 2 - Binimetinib and PF-02341066
|
Dose Expansion Phase
n=36 participants at risk
Binimetinib 30mg BD interval dose administration Days 1-21 every 28 days PF-02341066 (Crizotinib) 250mg OD Days 1-28 continuously Dosage determined following the recommended Phase II dose identification in the dose escalation phase.
|
|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.0%
3/25 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
13.9%
5/36 • Number of events 7 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.0%
3/25 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
22.2%
8/36 • Number of events 17 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.0%
7/25 • Number of events 9 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
25.0%
9/36 • Number of events 16 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Aphasia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
8.3%
3/36 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 6 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.0%
3/25 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
25.0%
9/36 • Number of events 13 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Asthenia
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
30.0%
6/20 • Number of events 10 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
25.0%
9/36 • Number of events 12 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Blepharitis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Albumin Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
20.0%
5/25 • Number of events 7 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
16.7%
6/36 • Number of events 9 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
35.0%
7/20 • Number of events 19 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
30.6%
11/36 • Number of events 25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Creatinine Increased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Surgical and medical procedures
Cataract Operation
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Chest Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Cognitive Disorder Cognitive Disorder
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Constipation
|
48.0%
12/25 • Number of events 20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
20.0%
4/20 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
25.0%
9/36 • Number of events 12 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Corneal Opacity
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
30.0%
6/20 • Number of events 9 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
10/25 • Number of events 15 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
70.0%
14/20 • Number of events 28 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
50.0%
18/36 • Number of events 29 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
20.0%
4/20 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Dry Eye
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Dry Mouth
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
8.3%
3/36 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Dysgeusia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
13.9%
5/36 • Number of events 8 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Ear and labyrinth disorders
Ear Disorder
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Ear infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema extremities
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema Face
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema Limbs
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema Lower Limb
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Edema of legs
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Electrocardiogram Qtc Interval Prolonged
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Epigastric Pain
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Exertional Dyspnoea
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Expressive Dysphasia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Eye disorder
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Eyelid Function Disorder
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
12.0%
3/25 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Fatigue
|
40.0%
10/25 • Number of events 18 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
50.0%
10/20 • Number of events 16 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
38.9%
14/36 • Number of events 30 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Fever
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
11.1%
4/36 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Finger cramps
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Flu like symptoms
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Foot Oedema
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Furunculosis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Generalised Oedema
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Genital Itching Nos
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Ggt Increased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Glucose Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Haematoma
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Renal and urinary disorders
Haematuria
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Hand Swelling
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Headache
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Hepatobiliary disorders
Hepatic Haemorrhage
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Herpes Lesion Intra-Oral
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Hot Flushes
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.0%
7/25 • Number of events 10 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
8.3%
3/36 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Hypokalaemia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Hypotension
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Insomnia
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Intercostal Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Intestinal Stoma Complication
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Intra-Abdominal Abscess
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Itchy Scalp
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Joint Instability
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
K+ Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Ldh Increased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Left Ventricular Ejection Fraction Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Leg Oedema
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Hepatobiliary disorders
Liver Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Localised Numbness
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Loose Stools
|
4.0%
1/25 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Psychiatric disorders
Low Mood
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Lymphoedema
|
4.0%
1/25 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Macular Rash
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Malaise
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Mucositis
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Muscle Ache
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Myalgia Of Lower Extremities
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Nausea
|
44.0%
11/25 • Number of events 20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
55.0%
11/20 • Number of events 16 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
55.6%
20/36 • Number of events 29 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Nausea And Vomiting
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Neck rash
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Neuropathic Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
8.3%
3/36 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleeds
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema
|
4.0%
1/25 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema Abdomen
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema Arms
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema Extremities
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema Legs
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema Limbs
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Oedema Of Lower Extremities
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Oesophagitis
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Oral Candida
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Orofacial Oedema
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Osteoarticular Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis Of Jaw
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Pain In Hip
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Pain In Thigh
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Pain Jaw
|
4.0%
1/25 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Painful Hips
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Papular Rash
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Paraesthesia
|
8.0%
2/25 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Paraesthesia Lower Limb
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Paronychia
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Parotiditis
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Periorbital Infection
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Peripheral Oedema
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Photophobia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Platelet Count Decreased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Postprandial Emesis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Postural Hypotension
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Prolapse Of Intestinal Stoma
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Protein Total Decreased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
13.9%
5/36 • Number of events 6 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Pustular Rash
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Qt Prolonged
|
16.0%
4/25 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.0%
7/25 • Number of events 8 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
35.0%
7/20 • Number of events 12 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
30.6%
11/36 • Number of events 21 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
36.0%
9/25 • Number of events 12 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
40.0%
8/20 • Number of events 12 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
36.1%
13/36 • Number of events 19 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Rash Face
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Rash On Legs & Arms
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Renal and urinary disorders
Renal Impairment
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Retinal Hemorrhage
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Retrosternal Chest Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Rib Pain
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Right Upper Quadrant Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Rigors
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Serous Discharge
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Skin Oedema
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Skin Peeling
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
15.0%
3/20 • Number of events 5 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Skin and subcutaneous tissue disorders
Skin Toxicity
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Sodium Decreased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Sore Gums
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
10.0%
2/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Stoma Site Bleeding
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Stomach Cramps
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Stomach Pain
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Subconjunctival Haemorrhage
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Swelling Of Hands
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Swelling Of Legs
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
General disorders
Teeth Chattering
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Transaminases Increased
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 4 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Transaminitis
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Tremor
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Troponin Increased
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Renal and urinary disorders
Urinary Frequency
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.6%
2/36 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Renal and urinary disorders
Urine Incontinence
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Vasovagal Attack
|
8.0%
2/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Vision Abnormal
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Eye disorders
Visual Disturbance
|
12.0%
3/25 • Number of events 3 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Visual Field Defect
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
10/25 • Number of events 20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
30.0%
6/20 • Number of events 9 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
52.8%
19/36 • Number of events 37 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Nervous system disorders
Weakness Left Or Right Side
|
4.0%
1/25 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Weight Gain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 2 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Investigations
Weight Loss
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
5.0%
1/20 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Infections and infestations
Wound Infection
|
4.0%
1/25 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/36 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
|
Injury, poisoning and procedural complications
Wound Pain
|
0.00%
0/25 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
0.00%
0/20 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
2.8%
1/36 • Number of events 1 • Adverse event monitoring starts from the time the time of consent until study completion, an average of 6 months.
The Investigator will monitor each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. The numbers for this outcome are presented by phase of study rather than dose level for a comparative review across both escalation and expansion phases as Adverse Events numbers at each dose level are very low, especially when separated by AE term. These events were collected irrespective of dose levels and cannot be separated into individual dose levels.
|
Additional Information
Heather House
University of Oxford Clinical Trials and Research Governance (CTRG)
Phone: 01865 572245
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place