Trial Outcomes & Findings for An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients With Solid Tumors (NCT NCT01945710)
NCT ID: NCT01945710
Last Updated: 2019-07-23
Results Overview
The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 2 of 3 or 2 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. For participants who continued to Cycle 2, the DLTs which occurred from 1st dose up to the day before Day 1 of Cycle 2 were counted. For participants who discontinued before Cycle 2, the DLTs which occurred from 1st dose up to Day 21 (Schedule 1) or Day 28 (Schedule 2) of Cycle 1 were counted. DLTs were evaluated and graded based on the National Cancer Institutes (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Schedule 1: Cycle 1 (21 days); Schedule 2: Cycle 1 (28 days)
Results posted on
2019-07-23
Participant Flow
Total 71 subjects were screened for entry into the study of which 62 were enrolled and 9 were screen failures. Of the 9 screen failures, 7 did not meet the inclusion/exclusion criteria, 1 experienced an adverse event that led to screening discontinuation, and 1 did not proceed to treatment in the study. Of the 62 enrolled, 58 subjects were treated.
Participant milestones
| Measure |
Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.0 milligram per square meter \[mg/m\^2\]) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.4 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
3
|
9
|
3
|
23
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
3
|
9
|
3
|
23
|
Reasons for withdrawal
| Measure |
Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.0 milligram per square meter \[mg/m\^2\]) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.4 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
5
|
4
|
3
|
2
|
7
|
3
|
19
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
0
|
3
|
1
|
1
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.4 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 12.22 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 2.08 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 6.13 • n=21 Participants
|
59.0 years
STANDARD_DEVIATION 16.52 • n=8 Participants
|
56.0 years
STANDARD_DEVIATION 9.31 • n=8 Participants
|
58.6 years
STANDARD_DEVIATION 9.94 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Schedule 1: Cycle 1 (21 days); Schedule 2: Cycle 1 (28 days)Population: Dose finding analysis set is all participants in the dose escalation part who completed Cycle 1 treatment and were evaluated for DLTs, and those who discontinued during Cycle 1 due to DLT.
The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 2 of 3 or 2 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. For participants who continued to Cycle 2, the DLTs which occurred from 1st dose up to the day before Day 1 of Cycle 2 were counted. For participants who discontinued before Cycle 2, the DLTs which occurred from 1st dose up to Day 21 (Schedule 1) or Day 28 (Schedule 2) of Cycle 1 were counted. DLTs were evaluated and graded based on the National Cancer Institutes (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=18 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=12 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Eribulin-LF
|
1.4 mg/m^2
|
1.5 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 of Dose Escalation part in Schedule 1 and Schedule 2Population: Dose-finding analysis set included all participants in the dose escalation part who completed Cycle 1 treatment and were evaluated for DLTs and those who discontinued during Cycle 1 due to DLTs.
DLTs were evaluated for both Schedule 1 and Schedule 2. DLTs were defined as neutropenia grade 4 that lasted more than 5 days, neutropenia grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count (ANC) less than 1.0 x 10\^9/liter, fever greater than or equal to 38.5 degrees Celsius), thrombocytopenia grade 4 of any duration, thrombocytopenia grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, hypersensitivity reaction grade 3 or 4 including allergy reactions or anaphylaxis; symptomatic bronchospasm requiring parenteral medication(s) with our without urticarial; allergy-related edema/angioedema, or other grade 3 or 4 clinically significant non-hematologic toxicities (except for inadequately treated nausea and /or vomiting) considered related to study drug. Participants with two or more adverse events in the same system organ class (or with the same preferred term) was counted only once for that system organ class (or preferred term).
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency
Stomatitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency
Transaminases increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency
Hypophosphataemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency
Febrile neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency
Neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 6 monthsPopulation: The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.
Safety was assessed by the monitoring and recording of all adverse events (AEs), and serious AEs (SAEs), regular monitoring of hematology, clinical chemistry, and urine values; periodic measurement of vital signs, electrocardiograms; and the performance of physical examinations. For each row category, a participant with two or more adverse events in that category is counted only once. Treatment-related TEAEs include TEAEs that were considered by the Investigator to be possibly or probably related to study drug and TEAEs with a missing relationship to study drug.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=7 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
TEAEs
|
7 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
23 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
TEAEs leading to drug withdrawal
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
TEAEs leading to dose reduction
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
TEAEs leading to dose interruption
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
Serious TEAEs
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
TEAEs leading to drug dose adjustment
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
17 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF
Treatment-related TEAEs
|
6 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 minutes (min) after the start of infusion (SOI), 5 min after the end of infusion (EOI), 0.5, 1, 2, 4, 6, 8, and 24 hours (h) postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different pharmacokinetic (PK) assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Eribulin-LF
|
1986.2 ng/mL
Standard Deviation 3084.77
|
1119.8 ng/mL
Standard Deviation 205.71
|
1211.3 ng/mL
Standard Deviation 293.35
|
665.3 ng/mL
Standard Deviation 125.13
|
1213.3 ng/mL
Standard Deviation 259.42
|
1473.3 ng/mL
Standard Deviation 47.26
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed as hours.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Eribulin-LF
|
1.95 hours
Interval 0.92 to 4.77
|
2.835 hours
Interval 1.5 to 5.0
|
2.00 hours
Interval 0.98 to 5.08
|
0.82 hours
Interval 0.23 to 0.95
|
1.13 hours
Interval 0.95 to 2.92
|
2.10 hours
Interval 1.18 to 2.17
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the mean and standard deviation for all participants and expressed in hours.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Plasma Half-life (t1/2) of Eribulin-LF
|
22.20 hours
Standard Deviation 2.212
|
23.62 hours
Standard Deviation 4.614
|
34.87 hours
Standard Deviation 19.374
|
36.83 hours
Standard Deviation 32.679
|
28.07 hours
Standard Deviation 9.386
|
21.13 hours
Standard Deviation 3.837
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-t), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms\*hour/milliliter (ng\*hr/mL).
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 Time of Last Quantifiable Concentration (AUC(0-t) ) of Eribulin-LF
|
27016.7 ng*h/mL
Standard Deviation 5022.91
|
30333.3 ng*h/mL
Standard Deviation 6068.83
|
33457.1 ng*h/mL
Standard Deviation 13808.68
|
12763.3 ng*h/mL
Standard Deviation 7917.72
|
32201.1 ng*h/mL
Standard Deviation 11854.28
|
49066.7 ng*h/mL
Standard Deviation 7605.48
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the mean and standard deviation for all participants and expressed in ng\*hr/mL.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of Eribulin-LF
|
27283.3 ng*h/mL
Standard Deviation 5087.80
|
30366.7 ng*h/mL
Standard Deviation 6062.23
|
33614.3 ng*h/mL
Standard Deviation 13874.13
|
12820.0 ng*h/mL
Standard Deviation 7870.43
|
32364.4 ng*h/mL
Standard Deviation 11900.94
|
49400.0 ng*h/mL
Standard Deviation 8179.85
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CL, which was then summarized as the mean and standard deviation for all participants and expressed as milliliter/hour (mL/h).
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Total Body Clearance (CL) of Eribulin-LF
|
60.15 mL/h
Standard Deviation 17.500
|
75.93 mL/h
Standard Deviation 22.818
|
80.90 mL/h
Standard Deviation 29.390
|
148.63 mL/h
Standard Deviation 61.905
|
95.82 mL/h
Standard Deviation 58.289
|
65.37 mL/h
Standard Deviation 8.465
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Vd, which was then summarized as the mean and standard deviation for all participants and expressed as milliliters (mL).
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=6 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vd) of Eribulin-LF
|
1953.3 mL
Standard Deviation 547.53
|
2091.7 mL
Standard Deviation 505.03
|
2310.0 mL
Standard Deviation 514.39
|
3793.3 mL
Standard Deviation 1866.61
|
2873.3 mL
Standard Deviation 1530.20
|
1993.3 mL
Standard Deviation 96.09
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CLr, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=4 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=5 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=5 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=1 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=5 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) of Eribulin-LF
|
4.833 mL/h
Standard Deviation 1.8621
|
8.698 mL/h
Standard Deviation 3.6476
|
13.316 mL/h
Standard Deviation 12.7962
|
3.800 mL/h
|
5.957 mL/h
Standard Deviation 5.8697
|
4.843 mL/h
Standard Deviation 0.9514
|
—
|
SECONDARY outcome
Timeframe: Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15Population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.
Urinalysis was performed at Screening, Baseline, Cycle 1/Day 15, and each study visit of every cycle thereafter. If urinalysis suggested a urinary tract infection, or if clinically indicated, a urine microscopy, culture, and sensitivity was to be performed at the institution's laboratory. If urine protein was ≥ 2+ on urinalysis, then a 24-hour urine collection was to be done to quantify the 24-hour urine protein excretion. The samples were analyzed for the amount of eribulin in the urine using liquid LC/MS method of analysis. Urine PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of fe, which was then summarized as the mean and standard deviation for all participants and expressed in percentage of eribulin-LF.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=4 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=5 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=5 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=1 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=5 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Fraction of Unchanged Eribulin-LF Excreted in the Urine (fe)
|
7.28 percent of eribulin-LF
Standard Deviation 1.597
|
9.88 percent of eribulin-LF
Standard Deviation 2.558
|
13.78 percent of eribulin-LF
Standard Deviation 7.379
|
4.70 percent of eribulin-LF
|
6.56 percent of eribulin-LF
Standard Deviation 5.327
|
7.30 percent of eribulin-LF
Standard Deviation 2.254
|
—
|
SECONDARY outcome
Timeframe: Baseline to first date of documented CR, PR, SD, or PD, assessed up to data cutoff date (17 May 2016), for up to approximately 3 years 7 monthsPopulation: The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.
BOR to treatment was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of eribulin-LF until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; at least 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at the end of 6 cycles or later after starting eribulin-LF.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=7 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response (BOR)
PR
|
14.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
CR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
SD
|
71.4 percentage of participants
|
16.7 percentage of participants
|
57.1 percentage of participants
|
33.3 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
PD
|
0 percentage of participants
|
66.7 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants With Best Overall Response (BOR)
Unknown
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
8.7 percentage of participants
|
SECONDARY outcome
Timeframe: From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 monthsPopulation: The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.
ORR was defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 criteria or target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was less than or equal to 10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=7 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR)
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0 percentage of participants
Interval 0.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 33.6
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
SECONDARY outcome
Timeframe: From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 monthsPopulation: The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.
DCR was the percentage of the participants who had BOR of CR, PR, and SD, based on assessments by each site investigator using RECIST v1.1. The minimum duration of SD was defined as 5 weeks (or 7 weeks for Schedules 1a and 2 in the Dose Escalation Part) following the date of the first dose of study drug in order for stable disease to be considered the best overall response. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=7 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Control Rate (DCR)
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
SECONDARY outcome
Timeframe: From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 monthsPopulation: The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.
CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) \[CR + PR + dSD\] based on RECIST v1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 6 months), as determined by the site Investigator.
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=7 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Benefit Rate (CBR)
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 33.6
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
SECONDARY outcome
Timeframe: From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 monthsPopulation: PFS data was not collected as this is a Phase I dose escalation design and was not the focus of the study.
PFS was defined as the time from the date of treatment start until progressive disease or death from any cause in the absence of progressive disease. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions as assessed by IRR using RECIST v1.1. The duration of PFS was calculated as end date minus date of first drug plus 1, based on assessments by the site Investigator. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), Schedule 1 (Cycle 1 Day 1); Schedule 2 (Cycle 1 Day 1 and Day 15)Population: The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment. Only participants with baseline and post-baseline values were reported.
The effects of eribulin-LF on cardiovascular repolarization were evaluated via 24-hour, 12-lead continuous Holter electrocardiogram (ECG) monitoring in Cycle 1, Day 1 for Schedule 1 and Day 1 and Day 15 of Schedule 2. Individual ECGs were extracted in triplicate from the Holter recordings at specified time points and were evaluated by a central laboratory. QT intervals were measured from Lead II and were corrected for heart rate (QTc) using Fridericia's (QTcF) and Bazett's (QTcB) correction factors. The primary QTc parameter was QTcF. Secondary parameters (QTcB, QT, QRS, and hazard ratio/heart rate (HR)) and waveforms (T-waves) were evaluated. BL= Baseline, PBL = post-Baseline, A,NCS = abnormal, not clinically significant, A, CS = abnormal, clinically significant
Outcome measures
| Measure |
Schedule 1: Total Escalation Cohorts
n=7 Participants
Eribulin-LF (1.0 mg/m\^2, 1.4 mg/m\^2, or 1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2: Total Dose Escalation and Expansion
n=6 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2, 1.5 mg/m\^2, or 2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 Participants
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 Participants
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 Participants
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=normal to PBL=normal
|
3 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
14 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=A,NCS to PBL=A,CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=A,CS to PBL=normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=A,CS to PBL=A,NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=normal to PBL=A,NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=normal to PBL=A,CS
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=A,NCS to PBL=normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=A,NCS to PBL=A,NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category
BL=A,CS to PBL=A,CS
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=7 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF
n=6 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.4 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 participants at risk
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 participants at risk
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Device leakage
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Device occlusion
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Fatigue
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Malaise
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Immune system disorders
Drug hypersensitivity
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Transaminases increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
Other adverse events
| Measure |
Schedule 1 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=7 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.4 mg/m^2 Eribulin-LF
n=6 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.4 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 1 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=7 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 of a 21-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.0 mg/m^2 Eribulin-LF
n=3 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 1.5 mg/m^2 Eribulin-LF
n=9 participants at risk
Dose Escalation Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Dose Escalation Cohort: 2.0 mg/m^2 Eribulin-LF
n=3 participants at risk
Dose Escalation Cohort: Eribulin-LF (2.0 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle starting at 1 mg/m\^2 escalating until intolerable toxicity, disease progression or death.
|
Schedule 2 Expansion Cohort: 1.5 mg/m^2 Eribulin-LF
n=23 participants at risk
Dose Expansion Cohort: Eribulin-LF (1.5 mg/m\^2) was administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
2/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
100.0%
3/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
43.5%
10/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Endocrine disorders
Cushingoid
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
2/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
66.7%
2/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
13.0%
3/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
71.4%
5/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
3/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
17.4%
4/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
17.4%
4/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
21.7%
5/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
50.0%
3/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
42.9%
3/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
26.1%
6/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
47.8%
11/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Lip dry
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
13.0%
3/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Fatigue
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
50.0%
3/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
39.1%
9/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Face oedema
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Infusion site erythema
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
General disorders
Suprapubic pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Immune system disorders
Drug hypersensitivity
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Oral candidiasis
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
2/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
3/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Lower respiratory tract infection
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
17.4%
4/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Blood uric acid increased
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
57.1%
4/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
2/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
57.1%
4/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
21.7%
5/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
13.0%
3/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
2/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Nervous system disorders
Lethargy
|
57.1%
4/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
66.7%
2/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
66.7%
2/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
13.0%
3/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
17.4%
4/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Nervous system disorders
Neurotoxicity
|
28.6%
2/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
2/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
8.7%
2/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
42.9%
3/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
50.0%
3/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
57.1%
4/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
33.3%
1/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
22.2%
2/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
66.7%
2/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
34.8%
8/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
4.3%
1/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Skin and subcutaneous tissue disorders
Spider naevus
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
11.1%
1/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Vascular disorders
Hot flush
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
16.7%
1/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
|
Vascular disorders
Vasodilatation
|
14.3%
1/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/6 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/7 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/9 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/3 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
0.00%
0/23 • From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 8 months
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported for the Safety Analysis Set. All adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.1. Participants who did not receive treatment were not analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER