Trial Outcomes & Findings for A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma (NCT NCT01677858)
NCT ID: NCT01677858
Last Updated: 2022-09-23
Results Overview
The MTD was defined as the highest carfilzomib dose at which \< 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows: Nonhematologic: * ≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting \< 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment) * ≥ grade 3 acute kidney injury (creatinine \> 3 x baseline or \> 4.0 mg/dL) lasting \> 72 hours * ≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) for \> 7 days * febrile neutropenia (ANC \< 1000/mm³ with a fever ≥ 38.3ºC) of any duration * grade 4 thrombocytopenia (\< 25 000/mm³) for \> 14 days, despite holding treatment * grade 3 or 4 thrombocytopenia (\< lower limit of normal) associated with \> grade 1 bleeding
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
116 participants
Primary outcome timeframe
28 days
Results posted on
2022-09-23
Participant Flow
This study was conducted at 32 centers in the United States. Participants were enrolled from September 2012 to September 2014.
In phase 1 participants were enrolled into 1 of 4 sequential dose-escalating cohorts to establish the maximum tolerated dose (MTD) of carfilzomib plus dexamethasone. In phase 2 participants were enrolled to evaluate the efficacy and safety of carfilzomib plus dexamethasone at the MTD established in phase 1.
Participant milestones
| Measure |
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
15
|
6
|
89
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
14
|
6
|
85
|
Reasons for withdrawal
| Measure |
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
3
|
13
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
0
|
12
|
|
Overall Study
Progressive Disease
|
2
|
1
|
9
|
3
|
43
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
15
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1: Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
67.5 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
105 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
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
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restrictive but ambulatory)
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
The MTD was defined as the highest carfilzomib dose at which \< 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows: Nonhematologic: * ≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting \< 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment) * ≥ grade 3 acute kidney injury (creatinine \> 3 x baseline or \> 4.0 mg/dL) lasting \> 72 hours * ≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) for \> 7 days * febrile neutropenia (ANC \< 1000/mm³ with a fever ≥ 38.3ºC) of any duration * grade 4 thrombocytopenia (\< 25 000/mm³) for \> 14 days, despite holding treatment * grade 3 or 4 thrombocytopenia (\< lower limit of normal) associated with \> grade 1 bleeding
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.Population: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Disease response was evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in BM. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \<100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
n=104 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
100 percentage of participants
Interval 29.2 to 100.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
74.2 percentage of participants
Interval 63.8 to 82.9
|
76.9 percentage of participants
Interval 67.6 to 84.6
|
SECONDARY outcome
Timeframe: Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.Population: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
n=104 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Clinical Benefit Response Rate
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
80.9 percentage of participants
Interval 71.2 to 88.5
|
83.7 percentage of participants
Interval 75.1 to 90.2
|
SECONDARY outcome
Timeframe: From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 monthsPopulation: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored. Participants were evaluated for disease response and progression by the investigator according to the IMWG-URC.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
n=104 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
13.6 months
Interval 6.4 to 20.7
|
NA months
Interval 41.7 to
Could not be estimated due to the low number of events
|
21.0 months
Interval 4.2 to
Could not be estimated due to the low number of events
|
12.9 months
Interval 3.9 to 20.0
|
15.3 months
Interval 10.0 to 20.2
|
16.2 months
Interval 10.2 to 21.0
|
SECONDARY outcome
Timeframe: From randomization until the data cut-off date of 22 July 2016; median follow-up time for TTP was 13.4 monthsPopulation: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Time to progression (TTP) was defined as the time from first dose to disease progression evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). TTP was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
n=104 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Time To Progression
|
13.6 months
Interval 6.4 to 20.7
|
NA months
Interval 41.7 to
Could not be estimated due to the low number of events
|
21.0 months
Interval 4.2 to
Could not be estimated due to the low number of events
|
12.9 months
Interval 3.9 to 20.0
|
16.2 months
Interval 10.2 to 20.2
|
17.2 months
Interval 10.6 to 21.7
|
SECONDARY outcome
Timeframe: From randomization until the data cut-off date of 22 July 2016; median follow-up time for DOR was 14.3 monthsPopulation: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone) with a best overall response of sCR, CR, VGPR, or PR.
Duration of response (DOR) was defined as the time from first evidence of PR or better to disease progression or death due to any cause. DOR was calculated using Kaplan-Meier methods; Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=1 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=14 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=66 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
n=80 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Duration of Response
|
18.9 months
Could not be estimated due to the low number of events
|
NA months
Interval 39.9 to
Could not be estimated due to the low number of events
|
16.3 months
Interval 3.3 to
Could not be estimated due to the low number of events
|
11.9 months
Interval 11.1 to 18.9
|
18.0 months
Interval 13.7 to 21.9
|
18.0 months
Interval 14.5 to 21.9
|
SECONDARY outcome
Timeframe: From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.Population: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
All adverse events
|
3 Participants
|
3 Participants
|
15 Participants
|
6 Participants
|
89 Participants
|
—
|
|
Number of Participants With Adverse Events
Adverse events ≥ grade 3
|
1 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
60 Participants
|
—
|
|
Number of Participants With Adverse Events
Serious adverse events
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
35 Participants
|
—
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of carfilzomib & dex
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
—
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of carfilzomib
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
—
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=26 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=21 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=5 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of Carfilzomib
|
0.25 hours
Interval 0.17 to 0.75
|
0.25 hours
Interval 0.08 to 0.58
|
0.25 hours
Interval 0.25 to 0.58
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=26 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=21 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=5 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Carfilzomib
|
789 ng/mL
Geometric Coefficient of Variation 65.5
|
2390 ng/mL
Geometric Coefficient of Variation 30.7
|
3090 ng/mL
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=26 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=21 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=5 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Carfilzomib
|
281 hr*ng/mL
Geometric Coefficient of Variation 52.7
|
1040 hr*ng/mL
Geometric Coefficient of Variation 21.7
|
1210 hr*ng/mL
Geometric Coefficient of Variation 31.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=25 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=16 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) fo Carfilzomib
|
259 hr*ng/mL
Geometric Coefficient of Variation 28.0
|
1040 hr*ng/mL
Geometric Coefficient of Variation 21.6
|
1160 hr*ng/mL
Geometric Coefficient of Variation 34.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=25 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=16 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve During the Dosing Interval (0-168 Hours) for Carfilzomib
|
259 hr*ng/mL
Geometric Coefficient of Variation 28.0
|
1040 hr*ng/mL
Geometric Coefficient of Variation 21.6
|
1160 hr*ng/mL
Geometric Coefficient of Variation 34.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=24 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=16 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution Observed at Steady State (Vss) for Carfilzomib
|
17.0 liters
Geometric Coefficient of Variation 133.3
|
14.2 liters
Geometric Coefficient of Variation 54.2
|
7.87 liters
Geometric Coefficient of Variation 78.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=25 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=15 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Terminal Half-life (T1/2,z) for Carfilzomib
|
0.648 hours
Geometric Coefficient of Variation 49
|
0.883 hours
Geometric Coefficient of Variation 24.6
|
0.816 hours
Geometric Coefficient of Variation 17.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=25 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=16 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Clearance of Carfilzomib After IV Infusion
|
147 liters/hour
Geometric Coefficient of Variation 31.0
|
131 liters/hour
Geometric Coefficient of Variation 29.6
|
138 liters/hour
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.
Outcome measures
| Measure |
Phase 1 Carfilzomib 45 mg/m²
n=24 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=16 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=4 Participants
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1+2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|---|
|
Mean Residence Time Observed From Time Zero to Infinity (MRT0-∞) for Carfilzomib
|
0.118 hours
Geometric Coefficient of Variation 130.5
|
0.108 hours
Geometric Coefficient of Variation 55.4
|
0.0571 hours
Geometric Coefficient of Variation 110.0
|
—
|
—
|
—
|
Adverse Events
Phase 1: Carfilzomib 45 mg/m²
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Carfilzomib 56 mg/m²
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Carfilzomib 70 mg/m²
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Phase 1: Carfilzomib 88 mg/m²
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2: Carfilzomib 70 mg/m²
Serious events: 35 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Carfilzomib 45 mg/m²
n=3 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Phase 1: Carfilzomib 45 mg/m²
n=3 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 56 mg/m²
n=3 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 70 mg/m²
n=15 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 1: Carfilzomib 88 mg/m²
n=6 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
Phase 2: Carfilzomib 70 mg/m²
n=89 participants at risk
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
6/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.2%
10/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.5%
12/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.1%
25/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.7%
22/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Amblyopia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Blindness
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual acuity reduced
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
6/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.4%
11/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
60.0%
9/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
29.2%
26/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Loose tooth
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
46.7%
7/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.4%
36/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tooth loss
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.6%
13/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
9/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Cyst
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
100.0%
3/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
60.0%
9/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
52.8%
47/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Infusion site pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.5%
20/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
46.7%
7/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.7%
22/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sluggishness
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Submandibular mass
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
9/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
80.0%
12/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.1%
25/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.2%
10/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.6%
13/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood sodium decreased
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.6%
13/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
9/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.9%
15/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.2%
18/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
9/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.7%
14/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.7%
14/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
6/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
4/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
29.2%
26/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.7%
4/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anger
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.4%
11/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
2/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
32.6%
29/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Irritability
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.1%
25/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
5/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.1%
25/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
7/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
3/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.6%
13/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
18.0%
16/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.3%
2/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
1/15 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER