Trial Outcomes & Findings for Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer (NCT NCT01901653)
NCT ID: NCT01901653
Last Updated: 2018-08-09
Results Overview
MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
82 participants
Primary outcome timeframe
The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 2 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 3 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC)
LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1b: Retreatment (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Retreatment (LCNEC)
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Maintenance (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
Phase 1b: Maintenance (LCNEC)
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
11
|
3
|
2
|
3
|
7
|
10
|
1
|
18
|
2
|
16
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
11
|
3
|
2
|
3
|
7
|
10
|
1
|
18
|
2
|
16
|
5
|
Reasons for withdrawal
| Measure |
Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 2 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 3 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8 (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC)
LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1b: Retreatment (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Retreatment (LCNEC)
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Maintenance (SCLC)
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
Phase 1b: Maintenance (LCNEC)
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
8
|
3
|
2
|
2
|
6
|
9
|
1
|
16
|
2
|
15
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Alive at Study Termination by Sponsor
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
Baseline Characteristics
Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase 1a: Cohort 1 (SCLC)
n=3 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 2 (SCLC)
n=1 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 3 (SCLC)
n=11 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4 (SCLC)
n=3 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5 (SCLC)
n=2 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6 (SCLC)
n=3 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7 (SCLC)
n=7 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8 (SCLC)
n=10 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 8 (LCNEC)
n=1 Participants
LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1b: Retreatment (SCLC)
n=18 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Retreatment (LCNEC)
n=2 Participants
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Maintenance (SCLC)
n=16 Participants
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
Phase 1b: Maintenance (LCNEC)
n=5 Participants
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
51 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
31 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
34 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
48 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
75 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
71 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
11 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
7 participants
n=115 Participants
|
10 participants
n=24 Participants
|
1 participants
n=42 Participants
|
18 participants
n=42 Participants
|
2 participants
n=42 Participants
|
16 participants
n=42 Participants
|
5 participants
n=36 Participants
|
82 participants
n=36 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
55 Participants
n=36 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.Population: All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug.
MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=41 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine
|
0.4 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months).Population: Subjects with at least one post-dose assessment. All LCNEC subjects were analyzed. No LCNEC subjects achieved CR or PR and, therefore, the ORR was 0%.
Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR). Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=67 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
n=8 Participants
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
ORR unconfirmed by Investigator
|
25 percentage of subjects
Interval 14.98 to 38.44
|
0 percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
ORR confirmed by Investigator
|
17 percentage of subjects
Interval 8.44 to 28.97
|
0 percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
ORR unconfirmed by IRC
|
27 percentage of subjects
Interval 16.14 to 40.96
|
0 percentage of subjects
Interval 0.0 to 39.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
ORR confirmed by IRC
|
16 percentage of subjects
Interval 7.77 to 28.8
|
0 percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months).Population: Subjects with at least one post-dose assessment. No LCNEC subjects achieved CR or PR, therefore DOR was not analyzed.
Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=67 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
DOR by INV
|
2.89 months
Interval 2.17 to 6.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DOR)
DOR by IRC
|
1.71 months
Interval 0.03 to 3.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months).Population: Subjects with at least one post-dose assessment.
Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=67 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
n=8 Participants
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
CBR unconfirmed by IRC
|
75 percentage of subjects
Interval 61.0 to 85.33
|
75 percentage of subjects
Interval 34.91 to 96.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate (CBR)
CBR unconfirmed by INV
|
73 percentage of subjects
Interval 59.73 to 83.64
|
88 percentage of subjects
Interval 47.35 to 99.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate (CBR)
CBR confirmed by INV
|
58 percentage of subjects
Interval 44.07 to 70.39
|
75 percentage of subjects
Interval 34.91 to 96.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate (CBR)
CBR confirmed by IRC
|
56 percentage of subjects
Interval 42.32 to 69.7
|
75 percentage of subjects
Interval 34.91 to 96.81
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months).Population: Subjects with at least one post-dose assessment.
Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=67 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
n=8 Participants
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
PFS by INV
|
2.79 months
Interval 2.33 to 3.71
|
3.07 months
Interval 1.45 to 6.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression-free Survival (PFS)
PFS by IRC
|
2.89 months
Interval 2.14 to 3.84
|
2.6 months
Interval 1.25 to 14.46
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months).Population: Subjects with at least one post-dose assessment.
Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive.
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=67 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
n=8 Participants
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
4.76 months
Interval 4.01 to 7.13
|
6.59 months
Interval 2.89 to 14.46
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of first dose to End of Dose CyclePopulation: All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.
The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle.
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=3 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
n=1 Participants
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
n=10 Participants
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
n=3 Participants
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
n=2 Participants
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
n=3 Participants
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
n=10 Participants
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
n=11 Participants
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC)
|
1.27 μg/mL
Geometric Coefficient of Variation 13
|
2.42 μg/mL
|
5.08 μg/mL
Geometric Coefficient of Variation 21
|
8.81 μg/mL
Geometric Coefficient of Variation 7
|
18.8 μg/mL
Geometric Coefficient of Variation 27
|
11.4 μg/mL
Geometric Coefficient of Variation 27
|
7.67 μg/mL
Geometric Coefficient of Variation 21
|
5.36 μg/mL
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: From Day 1 of first dose to End of Dose CyclePopulation: All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.
The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum.
Outcome measures
| Measure |
Rovalpituzumab Tesirine
n=3 Participants
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
|
LCNEC Subjects
n=1 Participants
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
|
Phase 1a: Cohort 3
n=10 Participants
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4
n=3 Participants
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5
n=2 Participants
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6
n=3 Participants
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7
n=10 Participants
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8
n=11 Participants
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC
|
12.3 μg•d/mL
Geometric Coefficient of Variation 22
|
26.3 μg•d/mL
|
45.6 μg•d/mL
Geometric Coefficient of Variation 32
|
97.3 μg•d/mL
Geometric Coefficient of Variation 21
|
142 μg•d/mL
Geometric Coefficient of Variation 18
|
107 μg•d/mL
Geometric Coefficient of Variation 28
|
64.8 μg•d/mL
Geometric Coefficient of Variation 36
|
45.0 μg•d/mL
Geometric Coefficient of Variation 34
|
Adverse Events
Phase 1a: Cohort 1 (SCLC)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a: Cohort 2 (SCLC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1a: Cohort 3 (SCLC)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 1a: Cohort 4 (SCLC)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a: Cohort 5 (SCLC)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1a: Cohort 6 (SCLC)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a: Cohort 7 (SCLC)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1a: Cohort 8 (SCLC)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 1a: Cohort 8 (LCNEC)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b: Retreatment (SCLC)
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Phase 1b: Retreatment (LCNEC)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1b: Maintenance (SCLC)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Phase 1b: Maintenance (LCNEC)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1a: Cohort 1 (SCLC)
n=3 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 2 (SCLC)
n=1 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 3 (SCLC)
n=11 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4 (SCLC)
n=3 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5 (SCLC)
n=2 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6 (SCLC)
n=3 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7 (SCLC)
n=7 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8 (SCLC)
n=10 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 8 (LCNEC)
n=1 participants at risk
LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1b: Retreatment (SCLC)
n=18 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Retreatment (LCNEC)
n=2 participants at risk
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Maintenance (SCLC)
n=16 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
Phase 1b: Maintenance (LCNEC)
n=5 participants at risk
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Blood Alkaline Phosphatase Increase
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Haemorrhage
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Asthenia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Fatigue
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Vascular disorders
Capillary Leak Syndrome
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
Other adverse events
| Measure |
Phase 1a: Cohort 1 (SCLC)
n=3 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 2 (SCLC)
n=1 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 3 (SCLC)
n=11 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 4 (SCLC)
n=3 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 5 (SCLC)
n=2 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 6 (SCLC)
n=3 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 7 (SCLC)
n=7 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
|
Phase 1a: Cohort 8 (SCLC)
n=10 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1a: Cohort 8 (LCNEC)
n=1 participants at risk
LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
|
Phase 1b: Retreatment (SCLC)
n=18 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Retreatment (LCNEC)
n=2 participants at risk
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles.
|
Phase 1b: Maintenance (SCLC)
n=16 participants at risk
SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
Phase 1b: Maintenance (LCNEC)
n=5 participants at risk
LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
4/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.8%
5/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
25.0%
4/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
2/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
25.0%
4/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Cardiac disorders
Pericardial Effusion
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
28.6%
2/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Eye disorders
Vision Blurred
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.8%
5/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
25.0%
4/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
3/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
2/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
4/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
44.4%
8/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
30.0%
3/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
44.4%
8/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
2/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
28.6%
2/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
22.2%
4/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
22.2%
4/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
60.0%
3/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Fatigue
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.3%
3/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
2/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
3/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
28.6%
2/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
60.0%
6/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
12/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
31.2%
5/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
5/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Oedema Peripheral
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
36.4%
4/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
38.9%
7/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
37.5%
6/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
60.0%
3/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
22.2%
4/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
25.0%
4/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Asthenia
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Face Oedema
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Chills
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
General disorders
Chest Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Lipase Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Amylase Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Blood Albumin Decreased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Weight Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Weight Decreased
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
42.9%
3/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
22.2%
4/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
37.5%
6/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
60.0%
3/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
6/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
31.2%
5/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
2/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
43.8%
7/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
22.2%
4/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
25.0%
4/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
30.0%
3/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.3%
3/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
55.6%
10/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
25.0%
4/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.3%
3/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
28.6%
2/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
2/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
16.7%
3/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
22.2%
4/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
60.0%
3/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
100.0%
1/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
14.3%
1/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
36.4%
4/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.8%
3/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
18.2%
2/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
37.5%
6/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
28.6%
2/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
66.7%
2/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.8%
5/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
27.3%
3/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
9.1%
1/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
5.6%
1/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
12.5%
2/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
20.0%
1/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
40.0%
2/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/11 • From date of first dose through 30-days following last dose (on average 85 days).
|
33.3%
1/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
50.0%
1/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/3 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/7 • From date of first dose through 30-days following last dose (on average 85 days).
|
10.0%
1/10 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/1 • From date of first dose through 30-days following last dose (on average 85 days).
|
11.1%
2/18 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/2 • From date of first dose through 30-days following last dose (on average 85 days).
|
6.2%
1/16 • From date of first dose through 30-days following last dose (on average 85 days).
|
0.00%
0/5 • From date of first dose through 30-days following last dose (on average 85 days).
|
Additional Information
Senior Director, Clinical Operations
AbbVie Stemcentrx
Phone: (650) 827-4879
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER