Trial Outcomes & Findings for A Confirmation Study of Eribulin in Combination With Capecitabine (NCT NCT01323530)
NCT ID: NCT01323530
Last Updated: 2021-01-11
Results Overview
DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count \[ANC\] less than 1.0\*10\^9/liter \[L\], fever of at least 38.5 degree celsius \[°C\]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2021-01-11
Participant Flow
Participants took part in the study at 13 investigative sites in Bulgaria, Russia, and United Kingdom from 26 January 2010 to 13 October 2015.
Phase 1b (Dose Escalation Phase): total 43 participants with solid tumors were screened, of which 9 were screen failures and 34 received study treatment; Phase 2 (Dose Confirmation Phase): total 54 female participants with breast cancer were screened, of which 12 were screen failures and 42 received study treatment.
Participant milestones
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
Participants received eribulin mesilate 1.2 milligrams per square meter (mg/m\^2), injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of progressive disease (PD), undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 1b (Dose Escalation Phase)
STARTED
|
8
|
6
|
5
|
3
|
6
|
6
|
0
|
|
Phase 1b (Dose Escalation Phase)
COMPLETED
|
5
|
4
|
4
|
3
|
3
|
3
|
0
|
|
Phase 1b (Dose Escalation Phase)
NOT COMPLETED
|
3
|
2
|
1
|
0
|
3
|
3
|
0
|
|
Phase 2 (Dose-confirmation Phase)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
42
|
|
Phase 2 (Dose-confirmation Phase)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
|
Phase 2 (Dose-confirmation Phase)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
Reasons for withdrawal
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
Participants received eribulin mesilate 1.2 milligrams per square meter (mg/m\^2), injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of progressive disease (PD), undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 1b (Dose Escalation Phase)
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Phase 1b (Dose Escalation Phase)
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
2
|
0
|
0
|
|
Phase 1b (Dose Escalation Phase)
Clinical Progression
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Phase 2 (Dose-confirmation Phase)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Phase 2 (Dose-confirmation Phase)
Clinical progression
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Phase 2 (Dose-confirmation Phase)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
|
Phase 2 (Dose-confirmation Phase)
Investigators decision
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Phase 2 (Dose-confirmation Phase)
Development of bladder cancer
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Confirmation Study of Eribulin in Combination With Capecitabine
Baseline characteristics by cohort
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=8 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
n=5 Participants
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
n=3 Participants
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
n=42 Participants
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
Total
n=76 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
61 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
61 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=24 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
76 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
75 Participants
n=24 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count \[ANC\] less than 1.0\*10\^9/liter \[L\], fever of at least 38.5 degree celsius \[°C\]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=8 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
n=5 Participants
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
n=3 Participants
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug until PD or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug.
ORR was defined as the percentage of participants who had either a confirmed complete response (CR) or partial response (PR). ORR was assessed based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR was summarized using the Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=42 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR)
|
42.9 percentage of participants
Interval 27.7 to 59.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug treatment start date until date of first documented evidence of CR or PR or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug. Here "overall number of participants analyzed" signifies participants who had CR or PR.
Time to response (CR or PR) was defined as the time from the first dose until first documented evidence of CR or PR (whichever status was recorded first). Time to response was assessed based on RECIST v 1.1. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. Time to response was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=18 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Response
|
44.0 days
Interval 42.0 to 84.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of the first CR or PR until the date of first documentation of PD or death or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug. Here "overall number of participants analyzed" signifies participants who had CR or PR.
DOR: time from first documented evidence of CR or PR until first documented sign of PD or death. DOR was assessed based on RECIST v 1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target/non-target) must have a reduction in their short axis to \>10 mm. PR: at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). DOR was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=18 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
|
261.0 days
Interval 161.0 to
Here, NA means that the upper limit of 95% confidence interval (CI) was not estimable due to an insufficient number of events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug until PD or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug.
SD rate was defined as the percentage of participants with a SD that lasted for a minimum of 5 weeks. SD rate was assessed based on RECIST version 1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR: at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=42 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Stable Disease (SD) Rate
|
38.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug until PD or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
Non-CR/Non-PD was for participants who had non-target disease only (minimum duration from randomization to Non-CR/Non-PD \>=7 weeks) and assessed by investigator based on RECIST v1.1. Non-CR/Non-PD: persistence of one or more non-target lesions, maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=8 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
n=5 Participants
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
n=3 Participants
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
n=6 Participants
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
n=42 Participants
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 1b and Phase 2: Percentage of Participants With Non-CR/Non-PD
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug until PD or 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug. Here "overall number of participants analyzed" signifies participants who had SD.
Duration of SD was measured from date of the first dose until progression. Duration of SD was assessed based on RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR: at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). Duration of SD was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=16 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Stable Disease (SD)
|
162.0 days
Interval 91.0 to 330.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug until PD or 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug.
DCR was defined as the percentage of participants with a confirmed CR, PR, or SD divided by the number of participants in the analysis set. DCR was assessed by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). DCR was summarized using the Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=42 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate (DCR)
|
81.0 percentage of participants
Interval 65.9 to 91.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug until PD or 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug.
CBR was defined as the percentage of participants with a confirmed CR, PR, or SD of at least 6 months duration (durable SD) divided by the number of participants in the analysis set. CBR was determined by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). CBR was summarized using the Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=42 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Clinical Benefit Rate (CBR)
|
57.1 percentage of participants
Interval 41.0 to 72.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug until PD or death due to any cause or 30 days after the last dose of study treatment (up to approximately 3.75 years)Population: The Dose-confirmation full analysis set included all participants who enrolled in the Dose-confirmation Cohort (Phase 2) and received at least 1 dose of drug.
PFS was defined as the time from the first dose date until PD or death due to any cause. PFS was determined by an investigator based on RECIST v1.1. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). PFS was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=42 Participants
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Progression-free Survival (PFS)
|
219.0 days
Interval 138.0 to 330.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 2: Eribulin Mesilate 1.4 mg/m^2
Serious events: 10 serious events
Other events: 39 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=8 participants at risk
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
n=6 participants at risk
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
n=5 participants at risk
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
n=3 participants at risk
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
n=6 participants at risk
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
n=6 participants at risk
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
n=42 participants at risk
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Ascites
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Heparin-induced Thrombocytopenia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Device related infection
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Electrocardiogram QT prolongation
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
Other adverse events
| Measure |
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)
n=8 participants at risk
Participants received eribulin mesilate 1.2 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)
n=6 participants at risk
Participants received eribulin mesilate 1.6 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2)
n=5 participants at risk
Participants received eribulin mesilate 2.0 mg/m\^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).
|
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2)
n=3 participants at risk
Participants received eribulin mesilate 0.7 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2)
n=6 participants at risk
Participants received eribulin mesilate 1.1 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2)
n=6 participants at risk
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 2).
|
Phase 2: Eribulin Mesilate 1.4 mg/m^2
n=42 participants at risk
Participants received eribulin mesilate 1.4 mg/m\^2, injection, intravenously, once, on Days 1 and 8, and capecitabine 1000 mg/m\^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 2.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Weight decreased
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
11.9%
5/42 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
100.0%
5/5 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Lip pain
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
1/8 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Catheter site erythema
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Catheter site related reaction
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Chest discomfort
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Peripheral swelling
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Localised infection
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Oral herpes
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Psychiatric disorders
Depressed mood
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Psychiatric disorders
Parasomnia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Renal and urinary disorders
Chromaturia
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
40.0%
2/5 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
2/3 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
4.8%
2/42 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Vascular disorders
Lymphoedema
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Plantar Erythema
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/42 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
2.4%
1/42 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
83.3%
5/6 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
81.0%
34/42 • Number of events 238 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
47.6%
20/42 • Number of events 73 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Asthenia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
11.9%
5/42 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
28.6%
12/42 • Number of events 24 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
4/6 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
80.0%
4/5 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
2/3 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 15 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
100.0%
6/6 • Number of events 24 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
28.6%
12/42 • Number of events 28 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
6/8 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
2/3 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
4/6 • Number of events 13 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
19.0%
8/42 • Number of events 30 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
37.5%
3/8 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
4/6 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
19.0%
8/42 • Number of events 35 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
14.3%
6/42 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
60.0%
3/5 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
100.0%
6/6 • Number of events 18 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
14.3%
6/42 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
40.0%
2/5 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
2/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
60.0%
3/5 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
1/3 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
35.7%
15/42 • Number of events 26 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
1/8 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 11 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
26.2%
11/42 • Number of events 19 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Lethargy
|
25.0%
2/8 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
4/6 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
40.0%
2/5 • Number of events 4 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
2/3 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
4/6 • Number of events 22 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
66.7%
4/6 • Number of events 15 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
19.0%
8/42 • Number of events 66 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
19.0%
8/42 • Number of events 21 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
9.5%
4/42 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
20.0%
1/5 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
14.3%
6/42 • Number of events 16 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 2 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
40.0%
2/5 • Number of events 7 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
33.3%
2/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
14.3%
6/42 • Number of events 10 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
16.7%
1/6 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
7.1%
3/42 • Number of events 3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
14.3%
6/42 • Number of events 15 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/5 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/3 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
0.00%
0/6 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
14.3%
6/42 • Number of events 9 • From date of first dose up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
The safety set included the group of participants who received study drug and had at least 1 post dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place