Trial Outcomes & Findings for A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer (NCT NCT01432886)
NCT ID: NCT01432886
Last Updated: 2016-10-07
Results Overview
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Up to 3 weeks
Results posted on
2016-10-07
Participant Flow
Participant milestones
| Measure |
E7389 With Weekly Trastuzumab
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
|
E7389 With Tri-weekly Trastuzumab
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
Baseline characteristics by cohort
| Measure |
E7389 With Weekly Trastuzumab
n=6 Participants
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
|
E7389 With Tri-weekly Trastuzumab
n=6 Participants
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 5.05 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 10.32 • n=7 Participants
|
56.9 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: The DLT analysis set included those participants who received at least one dose of study drug and had a DLT assessment in cycle 1 (3 weeks) without deviations from the eribulin mesylate/trastuzumab dosing regimens and other major protocol prescripts. Participants with a DLT, regardless of this criterion, were also included in the DLT analysis set.
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.
Outcome measures
| Measure |
E7389 With Weekly Trastuzumab
n=6 Participants
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
|
E7389 With Tri-weekly Trastuzumab
n=6 Participants
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 yearsPopulation: The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation.
The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.
Outcome measures
| Measure |
E7389 With Weekly Trastuzumab
n=6 Participants
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
|
E7389 With Tri-weekly Trastuzumab
n=6 Participants
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
6 Participants
|
6 Participants
|
Adverse Events
E7389 With Weekly Trastuzumab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
E7389 With Tri-weekly Trastuzumab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
E7389 With Weekly Trastuzumab
n=6 participants at risk
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
|
E7389 With Tri-weekly Trastuzumab
n=6 participants at risk
Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
66.7%
4/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
6/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
100.0%
6/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
6/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
100.0%
6/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Cardiac disorders
Atrioventricular block second degree
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Cardiac disorders
Palpitations
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Cheilitis
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Implant site pain
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Inflammation
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Infusion site extravasation
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Injection site reaction
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Malaise
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Infections and infestations
Tonsillitis
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Injury, poisoning and procedural complications
Excoriation
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Investigations
Blood creatine phosphokinase increased
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Investigations
Ejection fraction decreased
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
4/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
4/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
33.3%
2/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
83.3%
5/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
50.0%
3/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
4/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
|
Vascular disorders
Phlebitis
|
16.7%
1/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
0.00%
0/6 • From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation. A subject with two or more treatment emergent adverse events in the same system organ class/preferred term is counted only once for that system organ class/preferred term.
|
Additional Information
Tadashi Nakanishi
Eisai Co., Ltd.
Phone: 81-3-3817-5252
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER