Trial Outcomes & Findings for Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer (NCT NCT01670877)
NCT ID: NCT01670877
Last Updated: 2022-04-15
Results Overview
* Imaging for clinical benefit rate occurred at baseline (for an initial comparison scan) and every 2 cycles (28 day length) thereafter. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have had stable disease for at least 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Through completion of treatment (median treatment time of 90 days, full range 54-716 days)
Results posted on
2022-04-15
Participant Flow
Participant milestones
| Measure |
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part I and Part 2
STARTED
|
16
|
5
|
11
|
24
|
0
|
0
|
|
Part I and Part 2
COMPLETED
|
16
|
4
|
10
|
21
|
0
|
0
|
|
Part I and Part 2
NOT COMPLETED
|
0
|
1
|
1
|
3
|
0
|
0
|
|
Crossover
STARTED
|
0
|
0
|
0
|
0
|
3
|
5
|
|
Crossover
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
5
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part I and Part 2
Grade 2 vomiting and progressive disease
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part I and Part 2
Grade 3 diarrhea and withdrawal
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part I and Part 2
Grade 2 vomiting
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part I and Part 2
Grade 3 dizziness and progressive disease
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part I and Part 2
Grade 3 diarrhea and duodenal ulcer
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Baseline characteristics by cohort
| Measure |
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib Only (ER-)
n=5 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
63 years
n=7 Participants
|
58 years
n=5 Participants
|
64 years
n=4 Participants
|
61 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
24 participants
n=4 Participants
|
56 participants
n=21 Participants
|
|
HER2 Status
Activating
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
HER2 Status
Novel
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Histology Subtype
Ductal
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Histology Subtype
Lobular
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Histology Subtype
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Histology Subtype
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Tumor Grade
I/II
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Tumor Grade
II
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Tumor Grade
III
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Tumor Grade
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
I
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
II
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
IIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
IIB
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
III
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
IIIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
IIIC
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
IV
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Tumor Stage at Initial Diagnosis
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Through completion of treatment (median treatment time of 90 days, full range 54-716 days)Population: Only Part I participants were evaluable for this outcome measure.
* Imaging for clinical benefit rate occurred at baseline (for an initial comparison scan) and every 2 cycles (28 day length) thereafter. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have had stable disease for at least 6 months.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part I Only: Clinical Benefit Rate (CR+PR+SD≥6months) of Patients Who Received Neratinib Alone
|
—
|
—
|
—
|
—
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Through completion of treatment (median treatment time of 62 days, full range 56-413 days)Population: Only participants enrolled in the Part II ER-cohort are evaluable for this outcome measure. One participant was not evaluable in this cohort as the participant stopped treatment in cycle 1.
* Imaging for clinical benefit rate occurred at baseline (for an initial comparison scan) and every 2 cycles (28 day length) thereafter. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have had stable disease for at least 6 months.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=4 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II ER-cohort Only: Clinical Benefit Rate (CR+PR+SD≥6months) of Neratinib in Patients With Metastatic HER2-, ER- Breast Cancer That Carry HER2 Mutation
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)Population: Only participants enrolled in the Part II fulvestrant-naive ER+ cohort is evaluable for this outcome measure. One participant was not evaluable in this cohort as the participant stopped treatment in cycle 1.
* Imaging for clinical benefit rate occurred at baseline (for an initial comparison scan) and every 2 cycles (28 day length) thereafter. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have had stable disease for at least 6 months.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=10 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II Fulvestrant-naive ER+ Cohort Only: Clinical Benefit (CR+PR+SD≥6 Months) of Neratinib + Fulvestrant in Patients With Metastatic HER2- ER+ Fulvestrant-naive Breast Cancer That Carry HER2 Mutation
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through completion of treatment (median treatment time of 168 days, full range 28-671 days)Population: Only participants enrolled in the fulvestrant-treated ER+ cohort are evaluable for this outcome measure. Three participants were not evaluable in this cohort as the participants stopped treatment in cycle 1.
* Imaging for clinical benefit rate occurred at baseline (for an initial comparison scan) and every 2 cycles (28 day length) thereafter. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have had stable disease for at least 6 months.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=21 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II Fulvestrant-treated ER+ Cohort Only: Clinical Benefit Rate (CR+PR+SD≥6months) of Neratinib + Fulvestrant in Patients With Metastatic HER2- ER+ Fulvestrant-treated Breast Cancer That Carry HER2 Mutation
|
—
|
—
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up; follow-up was through 30 days following completion of treatment (median follow-up of 92 days, full range 86 days-443 days)Population: Only participants enrolled in the Part II ER-cohort are evaluable for this outcome measure. One participant was not evaluable in this cohort as the participant stopped treatment in cycle 1. The data represents exact number of weeks that each participant had progression-free survival. 2 participants with Activating mutation - S310F both had 8 weeks of PFS.
* Participants were followed for progressive disease from start of treatment until completion of follow-up. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=4 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) of Patients Treated With Neratinib Alone in Patients With Metastatic HER2- But HER2 Mutated Breast Cancer by ER Status and by HER2 Mutations (Activating Versus Unknown Significance)
Activating mutation - L7L755S
|
9 weeks
|
—
|
—
|
—
|
—
|
—
|
|
Progression-free Survival (PFS) of Patients Treated With Neratinib Alone in Patients With Metastatic HER2- But HER2 Mutated Breast Cancer by ER Status and by HER2 Mutations (Activating Versus Unknown Significance)
Activating mutation - S310F
|
8 weeks
|
—
|
—
|
—
|
—
|
—
|
|
Progression-free Survival (PFS) of Patients Treated With Neratinib Alone in Patients With Metastatic HER2- But HER2 Mutated Breast Cancer by ER Status and by HER2 Mutations (Activating Versus Unknown Significance)
Activating mutation - A775_G776insYVMA
|
17 weeks
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the time of enrollmentOutcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=5 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
ECD mutation : Ductal histology
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
ECD mutation : Other histology
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
Exon 20 ins mutation : Ductal histology
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
2 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
Exon 20 ins mutation : Other histology
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
2 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
KD mutation : Ductal histology
|
1 Participants
|
5 Participants
|
7 Participants
|
—
|
5 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
KD mutation : Other histology
|
1 Participants
|
3 Participants
|
10 Participants
|
—
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: A time of enrollment-Cancer cells are graded when they are removed from the breast. The grade is based on how much the cancer cells look like normal cells. * A low grade number (grade 1) usually means the cancer is slower-growing and less likely to spread. * An intermediate grade number (grade 2) means the cancer is growing faster than a grade 1 cancer but slower than a grade 3 cancer. * A high grade number (grade 3) means a faster-growing cancer that's more likely to spread.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=5 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
ECD mutation : Tumor grade I/II
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
2 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
ECD mutation : Tumor grade III
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
ECD mutation : Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
Exon 20 ins mutation : Tumor grade I/II
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
1 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
Exon 20 ins mutation : Tumor grade III
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
3 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
Exon 20 ins mutation : Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
KD mutation : Tumor grade I/II
|
0 Participants
|
4 Participants
|
11 Participants
|
—
|
6 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
KD mutation : Tumor grade III
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
3 Participants
|
—
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
KD mutation : Unknown
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At time of enrollment* Staging occurred at initial diagnosis after physical exam, mammogram, and other diagnostic imaging tests. The staging also takes into account pathology reports from the breast biopsy or surgery. * Stage I has a better outcome than Stage IV.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=5 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
ECD mutation : Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
ECD mutation : Stage I
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
ECD mutation : Stage II
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
3 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
ECD mutation : Stage III
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
ECD mutation : Stage IV
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
Exon 20 ins mutation : Stage I
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
Exon 20 ins mutation : Stage II
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
Exon 20 ins mutation : Stage III
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
1 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
Exon 20 ins mutation : Stage IV
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
Exon 20 ins mutation : Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
KD mutation : Stage I
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
2 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
KD mutation : Stage II
|
1 Participants
|
2 Participants
|
6 Participants
|
—
|
2 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
KD mutation : Stage III
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
3 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
KD mutation : Stage IV
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
1 Participants
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
KD mutation : Unknown
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up; follow-up was through 30 days following completion of treatment (median follow-up of 142 days, full range 54-800 days)Population: The number analyzed for each row adds up to overall total number analyzed.
* Progression-free survival is defined as the number of weeks from start of treatment until disease progression or death. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=5 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Correlate the Presence of HER2 Mutation Subtype With Progression-free Survival
ECD mutation
|
8.0000 weeks
The sample size is too small to calculate the 95% confidence interval.
|
48.5000 weeks
Interval 16.0 to 81.0
|
3.0000 weeks
Interval 1.0 to 24.0
|
—
|
11.0000 weeks
Interval 9.0 to 32.0
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Progression-free Survival
Exon 20 ins mutation
|
17.0000 weeks
The sample size is too small to calculate the 95% confidence interval.
|
26.000 weeks
The sample size is too small to calculate the 95% confidence interval.
|
36.5000 weeks
Interval 9.0 to 68.0
|
—
|
26.0000 weeks
Interval 8.0 to 75.0
|
—
|
|
Correlate the Presence of HER2 Mutation Subtype With Progression-free Survival
KD mutation
|
6.5000 weeks
Interval 4.0 to 9.0
|
8.0000 weeks
Interval 1.0 to 24.0
|
16.0000 weeks
Interval 9.0 to 27.0
|
—
|
9.0000 weeks
Interval 3.0 to 31.0
|
—
|
SECONDARY outcome
Timeframe: Through completion of treatment (median treatment time of 62 days, full range 56-413 days)Population: Only participants enrolled in the Part II ER-cohort are evaluable for this outcome measure. One participant was not evaluable in this cohort as the participant stopped treatment in cycle 1.
* Progression-free survival is defined as the number of weeks from start of treatment until disease progression or death. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=4 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II ER-cohort Only: Progression-free Survival (PFS)
|
8.5 weeks
Interval 8.0 to
There were too few participants with an event to calculate the upper limit of the confidence interval.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)Population: Only participants enrolled in the Part II fulvestrant-naive ER+ cohort is evaluable for this outcome measure. One participant was not evaluable in this cohort as the participant stopped treatment in cycle 1.
* Progression-free survival is defined as the number of weeks from start of treatment until disease progression or death. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=10 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II Fulvestrant-naive ER+ Cohort Only: Progression-free Survival (PFS)
|
—
|
20 weeks
Interval 8.0 to
There were too few participants with an event to calculate the upper limit of the confidence interval.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of treatment (median treatment time of 168 days, full range 28-671 days)Population: Only participants enrolled in the fulvestrant-treated ER+ cohort are evaluable for this outcome measure. Three participants were not evaluable in this cohort as the participants stopped treatment in cycle 1.
* Progression-free survival is defined as the number of weeks from start of treatment until disease progression or death. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=21 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II Fulvestrant-treated ER+ Cohort Only: Progression-free Survival (PFS)
|
—
|
—
|
24 weeks
Interval 15.7 to 31.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up; follow-up was through 28 days following completion of treatment (median follow-up of 140 days, full range 52-798 days)-CTCAE v 4.0 will be used to record adverse events. Related includes those possibly, probably, or definitely related to the treatment regimen.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
n=5 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
n=3 Participants
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
n=16 Participants
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
n=5 Participants
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Diarrhea
|
5 Participants
|
8 Participants
|
20 Participants
|
0 Participants
|
15 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hot flashes
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hypotension
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dry mouth
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Anemia
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
LVEF Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Heart failure with preserved ejection fraction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Tinnitus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dry eye
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Abdominal cramping
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Abdominal pain
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Bloating
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Constipation
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dyspepsia
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Flatulence
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Mucositis oral
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Nausea
|
3 Participants
|
4 Participants
|
11 Participants
|
0 Participants
|
9 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Stomach pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Alkaline phosphatase decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Stomatitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Vomiting
|
1 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Fatigue
|
1 Participants
|
5 Participants
|
12 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Fever
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Generalized weakness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Rhinitis infective
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Upper respiratory infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Urinary tract infection
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Alaline aminotransferase increased
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Aspartate aminotransferase increased
|
0 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
CD4 lymphocytes decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Creatinine increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Ejection fraction decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
INR increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Lymphocyte count decreased
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Weight loss
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
White blood cell decreased
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Anorexia
|
1 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dehydration
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hypercalcemia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hyperglycemia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hyperkalemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hypoalbuminemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hypocalcemia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hypokalemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hyponatremia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hypophosphatemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Arthralgia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Back pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Bone pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Flank pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Generalized muscle weakness
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Joint range of motion decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Leg cramp
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Muscle weakness left sided
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Muscle weakness lower limb
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Myalgia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Pain at injection site
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Pain in extremity
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dizziness
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dysgeusia
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Headache
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Peripheral sensory neuropathy
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Syncope
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Depression
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dry skin
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Insomnia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Acute kidney injury
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Urinary tract obstruction
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Urine discoloration
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Urine odor
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Cough
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dyspnea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Epistaxis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Hoarseness
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Postnasal drip
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Rhinorrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Alopecia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Dry hair
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Nail changes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Pruritus
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Rash acneiform
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Rash maculopapular
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Skin hyperpigmentation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Sterile abscess at subcutaneous injection site
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)Population: Only participants enrolled in the Part II fulvestrant-naive ER+ cohort is evaluable for this outcome measure. One participant was not evaluable in this cohort as the participant stopped treatment in cycle 1.
* RR is defined as number of participants with complete response or partial response as best response. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=10 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II Fulvestrant-naive ER+ Cohort Only: Response Rate (RR)
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through completion of treatment (median treatment time of 168 days, full range 28-671 days)Population: Only participants enrolled in the fulvestrant-treated ER+ cohort are evaluable for this outcome measure. Three participants were not evaluable in this cohort as the participants stopped treatment in cycle 1.
* RR is defined as number of participants with complete response or partial response as best response. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=21 Participants
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Part II Fulvestrant-treated ER+ Cohort Only: Response Rate (RR)
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
Adverse Events
Part I: Neratinib Only
Serious events: 5 serious events
Other events: 16 other events
Deaths: 10 deaths
Part II: Neratinib Only (ER-)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 5 deaths
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
Serious events: 9 serious events
Other events: 24 other events
Deaths: 9 deaths
Crossover: Neratinib + Trastuzumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Crossover: Neratinib + Fulvestrant + Trastuzumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Part I: Neratinib Only
n=16 participants at risk
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib Only (ER-)
n=5 participants at risk
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 participants at risk
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 participants at risk
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
n=3 participants at risk
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
n=5 participants at risk
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to disease progression
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
INR increased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Creatinine increased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Cardiac disorders
Atrial flutter
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Bell's palsy
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Expressive aphasia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
Other adverse events
| Measure |
Part I: Neratinib Only
n=16 participants at risk
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib Only (ER-)
n=5 participants at risk
-Patients will receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive)
n=11 participants at risk
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx)
n=24 participants at risk
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Crossover: Neratinib + Trastuzumab
n=3 participants at risk
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will continue to receive neratinib PO daily on Days 1-28. Each cycle is 4 weeks.
|
Crossover: Neratinib + Fulvestrant + Trastuzumab
n=5 participants at risk
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen. Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks. A cycle will be defined as 28 days. Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15). Each cycle is 4 weeks.
|
|---|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
CD4 lymphocytes decreased
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Cardiac troponin increased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Creatinine increased
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Wound infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Injury, poisoning and procedural complications
Finger pad cut off
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
4/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.8%
5/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
25.0%
6/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
4/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
45.5%
5/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
8/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
25.0%
6/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
66.7%
2/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenia purpura
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Cardiac disorders
LVEF decrease
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Double vision
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Floaters
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Itchy eye
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Peripheral vision change
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Eye disorders
Styes
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Abdominal cramping
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Abdominal fullness
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.8%
5/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Bloating
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Constipation
|
56.2%
9/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
37.5%
9/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
16/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
100.0%
5/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
81.8%
9/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
91.7%
22/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
25.0%
6/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Gastrointestinal illness
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Nausea
|
68.8%
11/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
80.0%
4/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
36.4%
4/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
50.0%
12/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Stomach pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Gastrointestinal disorders
Vomiting
|
62.5%
10/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
25.0%
6/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
60.0%
3/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Changes in dentition
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Chills
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Edema face
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
66.7%
2/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Failure-to-thrive
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
45.5%
5/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
50.0%
12/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Fever
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.8%
5/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Flu like symptoms
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Generalized weakness
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Localized edema
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
General disorders
Pain
|
25.0%
4/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Bilateral breast infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Cold
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Gum infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Shingles
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Sinusitis
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Stomach bug
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Strep throat
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
Weight loss
|
31.2%
5/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Investigations
White blood cell decreased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
10/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
63.6%
7/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
41.7%
10/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.8%
5/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
4/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
31.2%
5/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.8%
5/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
4/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Finger pain
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Leg cramp
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Pain at injection site
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Musculoskeletal and connective tissue disorders
Shoulder tendonitis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New brain metastases
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.8%
5/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Expressive aphasia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
40.0%
2/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Sinus pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Nervous system disorders
Syncope
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Psychiatric disorders
Anxiety
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Bilateral ureteral stent placement
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Renal and urinary disorders
Urine odor
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chest tightness
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
25.0%
6/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
27.3%
3/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
12.5%
3/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nose irritation
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Bug bite
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Dry hair
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
New skin lesion
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
16.7%
4/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
12.5%
2/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
20.0%
1/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Skin and subcutaneous tissue disorders
Sterile abscess at subcutaneous injection site
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Surgical and medical procedures
Bilateral percutaneous nephrostomy tubes placement
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Surgical and medical procedures
Chest wall port placement
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Surgical and medical procedures
Nephrostomy tubes exchange
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Vascular disorders
Hot flashes
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
18.2%
2/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
33.3%
1/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
4.2%
1/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
9.1%
1/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
8.3%
2/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/11 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/24 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/3 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
0.00%
0/5 • Adverse events were tracked from start of treatment up to 28 days following the last day of study treatment. Median follow-up was 40 days, full range 52-798 days.
|
Additional Information
Cynthia Ma, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-362-9383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place