Trial Outcomes & Findings for A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma (NCT NCT01063907)
NCT ID: NCT01063907
Last Updated: 2024-04-25
Results Overview
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
95 participants
Primary outcome timeframe
21 day cycle, up to 52 weeks
Results posted on
2024-04-25
Participant Flow
Study centers in the USA and the UK participated in the Phase 1 portion, and study centers in the USA, UK, and Philippines participated in the Phase 2 portion.
Participant milestones
| Measure |
Phase 1: KW-2478 and Bortezomib
The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m\^2) and bortezomib(1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
|
Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2
The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m\^2/bortezomib1.3 mg/m\^2).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
80
|
|
Overall Study
COMPLETED
|
15
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
KW-2478 and Bortezomib
n=95 Participants
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m\^2) and Bortezomib(1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2 / Bortezomib 1.3 mg/m\^2).
|
|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
57 participants
n=5 Participants
|
|
Body Surface Area (BSA)
|
1.87 m^2
STANDARD_DEVIATION 0.27 • n=5 Participants
|
PRIMARY outcome
Timeframe: 21 day cycle, up to 52 weeksPopulation: All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).
Outcome measures
| Measure |
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=95 Participants
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
n=3 Participants
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
n=3 Participants
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=6 Participants
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=80 Participants
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Subjects with Any TEAE
|
95 participants
|
3 participants
|
3 participants
|
3 participants
|
6 participants
|
80 participants
|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Related TEAE
|
88 participants
|
3 participants
|
3 participants
|
2 participants
|
6 participants
|
74 participants
|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Moderate (CTCAE 2) TEAE
|
22 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
22 participants
|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Life Threatening TEAE
|
13 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
12 participants
|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Severe (CTCAE 3) TEAE
|
54 participants
|
3 participants
|
2 participants
|
2 participants
|
5 participants
|
42 participants
|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Subjects with Any DLT
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
Serious Treatment-Emergent AE
|
48 participants
|
2 participants
|
3 participants
|
3 participants
|
4 participants
|
36 participants
|
SECONDARY outcome
Timeframe: PK collected Day 11 of 21-day cyclePopulation: The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
Outcome measures
| Measure |
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
n=3 Participants
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
n=6 Participants
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
Phase 1: PK Absorption Tmax hr Day 11
|
1.03 hr
Standard Deviation 0.0441
|
1.03 hr
Standard Deviation 0.0481
|
1.11 hr
Standard Deviation 0.129
|
1.07 hr
Standard Deviation 0.0638
|
—
|
—
|
SECONDARY outcome
Timeframe: PK collected Day 11 of 21-day cyclePopulation: The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
Outcome measures
| Measure |
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
n=3 Participants
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
n=6 Participants
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
Phase 1: PK Exposure Cmax ng/mL Day 11
|
7910 ng/mL
Standard Deviation 5360
|
41000 ng/mL
Standard Deviation 64100
|
5990 ng/mL
Standard Deviation 2720
|
5280 ng/mL
Standard Deviation 2290
|
—
|
—
|
SECONDARY outcome
Timeframe: PK collected Day 11 of 21-day cyclePopulation: The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
Outcome measures
| Measure |
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
n=3 Participants
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
n=6 Participants
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11
|
7940 hr*ng/mL
Standard Deviation 2580
|
26200 hr*ng/mL
Standard Deviation 36700
|
7190 hr*ng/mL
Standard Deviation 2150
|
6040 hr*ng/mL
Standard Deviation 2280
|
—
|
—
|
SECONDARY outcome
Timeframe: PK collected Day 11 of 21-day cyclePopulation: The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.
Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.
Outcome measures
| Measure |
Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.
The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\^2) and Bortezomib (1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.
The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
n=3 Participants
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
n=3 Participants
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
n=6 Participants
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2/Bortezomib 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
Phase 1: PK Elimination t½ hr Day 11
|
1.88 hr
Standard Deviation 0.076
|
2.02 hr
Standard Deviation 0
|
1.84 hr
Standard Deviation 0.206
|
1.77 hr
Standard Deviation 0.262
|
—
|
—
|
Adverse Events
Phase 1 and 2: KW-2478 and Bortezomib
Serious events: 48 serious events
Other events: 95 other events
Deaths: 0 deaths
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
Serious events: 36 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 and 2: KW-2478 and Bortezomib
n=95 participants at risk
KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2
n=3 participants at risk
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2
n=3 participants at risk
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2
n=3 participants at risk
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
n=6 participants at risk
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
n=80 participants at risk
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m\^2/BTZ 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Cardiac disorders
Angina unstable
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Right ventricular failure
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Eye disorders
Vision blurred
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
4/95 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
3/95 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Chest pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
General disorders
Oedema peripheral
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
General disorders
Pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Pyrexia
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Appendicitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Catheter sepsis
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Listeriosis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
4.2%
4/95 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Lung infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Lung infection pseudomonal
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
7.4%
7/95 • Number of events 7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
7.5%
6/80 • Number of events 6
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Investigations
Blood creatinine increased
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Investigations
Troponin T increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Investigations
Viral test positive
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Weight decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Nervous system disorders
Presyncope
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Neurogenic bladder
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
4/95 • Number of events 5
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
Other adverse events
| Measure |
Phase 1 and 2: KW-2478 and Bortezomib
n=95 participants at risk
KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
|
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2
n=3 participants at risk
Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2
n=3 participants at risk
Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2
n=3 participants at risk
Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
n=6 participants at risk
Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
|
Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2
n=80 participants at risk
Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m\^2/BTZ 1.3 mg/m\^2).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
3.2%
3/95 • Number of events 5
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
57.9%
55/95 • Number of events 114
|
100.0%
3/3 • Number of events 11
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
83.3%
5/6 • Number of events 6
|
56.2%
45/80 • Number of events 93
|
|
Gastrointestinal disorders
Oral pain
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Gingival pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Glossodynia
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
1.1%
1/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 3
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
17.9%
17/95 • Number of events 30
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
17.5%
14/80 • Number of events 27
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.8%
15/95 • Number of events 37
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
17.5%
14/80 • Number of events 36
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
19/95 • Number of events 41
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
21.2%
17/80 • Number of events 39
|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Extrasystoles
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Cardiac disorders
Tachycardia
|
2.1%
2/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Eye disorders
Abnormal sensation in eye
|
1.1%
1/95 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Eye disorders
Blepharitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Conjunctival hyperaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Eye disorders
Diplopia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Dry eye
|
4.2%
4/95 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Eye disorders
Erythema of eyelid
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Eye disorders
Eye discharge
|
3.2%
3/95 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Eye irritation
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Eye pain
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Eye disorders
Eye pruritus
|
2.1%
2/95 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Eye swelling
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Eye disorders
Eyelid disorder
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Eyelids pruritus
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Eye disorders
Foreign body sensation in eyes
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
12.6%
12/95 • Number of events 15
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
10.0%
8/80 • Number of events 10
|
|
Eye disorders
Macular degeneration
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Metamorphopsia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Eye disorders
Ocular hyperaemia
|
2.1%
2/95 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Photophobia
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Eye disorders
Retinal disorder
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Eye disorders
Vision blurred
|
16.8%
16/95 • Number of events 19
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
15.0%
12/80 • Number of events 15
|
|
Eye disorders
Visual acuity reduced
|
4.2%
4/95 • Number of events 5
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
5/95 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
6.2%
5/80 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal distension
|
13.7%
13/95 • Number of events 19
|
66.7%
2/3 • Number of events 6
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
11.2%
9/80 • Number of events 11
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
17/95 • Number of events 31
|
66.7%
2/3 • Number of events 5
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 4
|
16.2%
13/80 • Number of events 21
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
11/95 • Number of events 12
|
100.0%
3/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
10.0%
8/80 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Anal haemorrhage
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
44.2%
42/95 • Number of events 71
|
100.0%
3/3 • Number of events 8
|
66.7%
2/3 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
41.2%
33/80 • Number of events 54
|
|
Gastrointestinal disorders
Diarrhoea
|
73.7%
70/95 • Number of events 199
|
100.0%
3/3 • Number of events 29
|
66.7%
2/3 • Number of events 9
|
100.0%
3/3 • Number of events 7
|
66.7%
4/6 • Number of events 6
|
72.5%
58/80 • Number of events 148
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
7/95 • Number of events 7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
7.5%
6/80 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
13.7%
13/95 • Number of events 20
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
12.5%
10/80 • Number of events 16
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Proctalgia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Tongue coated
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
38/95 • Number of events 72
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
43.8%
35/80 • Number of events 67
|
|
General disorders
Asthenia
|
15.8%
15/95 • Number of events 17
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
16.2%
13/80 • Number of events 15
|
|
General disorders
Catheter site erythema
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Catheter site haemorrhage
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Catheter site pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Catheter site related reaction
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Catheter thrombosis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
General disorders
Chest discomfort
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
General disorders
Chest pain
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Chills
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
General disorders
Cyst
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Facial pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Fatigue
|
53.7%
51/95 • Number of events 101
|
66.7%
2/3 • Number of events 6
|
100.0%
3/3 • Number of events 10
|
66.7%
2/3 • Number of events 2
|
50.0%
3/6 • Number of events 4
|
51.2%
41/80 • Number of events 79
|
|
General disorders
Feeling cold
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Gait disturbance
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Influenza like illness
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 4
|
|
General disorders
Infusion related reaction
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
General disorders
Infusion site haematoma
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Infusion site pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Injection site haematoma
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
General disorders
Irritability
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Malaise
|
4.2%
4/95 • Number of events 6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 6
|
|
General disorders
Mass
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
General disorders
Mucosal inflammation
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
General disorders
Oedema peripheral
|
12.6%
12/95 • Number of events 17
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
11.2%
9/80 • Number of events 12
|
|
General disorders
Pain
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
General disorders
Pyrexia
|
12.6%
12/95 • Number of events 15
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
12.5%
10/80 • Number of events 11
|
|
General disorders
Swelling
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Bronchiectasis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Infections and infestations
Bronchitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Conjunctivitis infective
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Cystitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
1.1%
1/95 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Eye infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Eyelid infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/95 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Infections and infestations
Gingival infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Hordeolum
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Infection
|
2.1%
2/95 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Localised infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
14.7%
14/95 • Number of events 19
|
66.7%
2/3 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
13.8%
11/80 • Number of events 14
|
|
Infections and infestations
Lung infection
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
7/95 • Number of events 8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
8.8%
7/80 • Number of events 8
|
|
Infections and infestations
Onychomycosis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Orchitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Infections and infestations
Rhinitis
|
7.4%
7/95 • Number of events 13
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/6
|
7.5%
6/80 • Number of events 10
|
|
Infections and infestations
Sepsis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Skin candida
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
14.7%
14/95 • Number of events 15
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.2%
13/80 • Number of events 14
|
|
Infections and infestations
Urinary tract infection
|
6.3%
6/95 • Number of events 7
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
6.2%
5/80 • Number of events 6
|
|
Infections and infestations
Viral infection
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Injury, poisoning and procedural complications
Human bite
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medical device site reaction
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Investigations
Blood alkaline phosphatase increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Investigations
Blood magnesium decreased
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Investigations
Blood potassium decreased
|
4.2%
4/95 • Number of events 5
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Investigations
Blood pressure increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Blood sodium decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Body temperature increased
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Investigations
C-reactive protein increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Electrocardiogram QT prolonged
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Investigations
Eosinophil count increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Heart rate decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
5.3%
5/95 • Number of events 11
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
5.0%
4/80 • Number of events 10
|
|
Investigations
Neutrophil count increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Platelet count decreased
|
3.2%
3/95 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 5
|
|
Investigations
Protein total increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Weight decreased
|
9.5%
9/95 • Number of events 10
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
8.8%
7/80 • Number of events 7
|
|
Investigations
Weight increased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.5%
28/95 • Number of events 44
|
66.7%
2/3 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
31.2%
25/80 • Number of events 38
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
6/95 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
6.2%
5/80 • Number of events 5
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
1/95 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/80
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.1%
1/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
5/95 • Number of events 7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
6.2%
5/80 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.4%
8/95 • Number of events 13
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
8.8%
7/80 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.2%
4/95 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.1%
2/95 • Number of events 10
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 10
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.6%
12/95 • Number of events 15
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
13.8%
11/80 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
12/95 • Number of events 13
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
12.5%
10/80 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
1.1%
1/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
5/95 • Number of events 6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.1%
1/95 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.1%
1/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.5%
10/95 • Number of events 13
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
10/80 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.2%
4/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.5%
10/95 • Number of events 10
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
8.8%
7/80 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.6%
12/95 • Number of events 17
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
12.5%
10/80 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
1.2%
1/80 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
5/95 • Number of events 6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.8%
15/95 • Number of events 19
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.2%
13/80 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Nervous system disorders
Ageusia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Areflexia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Balance disorder
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Nervous system disorders
Depressed level of consciousness
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Nervous system disorders
Dizziness
|
26.3%
25/95 • Number of events 33
|
100.0%
3/3 • Number of events 8
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
22.5%
18/80 • Number of events 21
|
|
Nervous system disorders
Dizziness exertional
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
13.7%
13/95 • Number of events 13
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
10/80 • Number of events 10
|
|
Nervous system disorders
Head discomfort
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Headache
|
24.2%
23/95 • Number of events 41
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
25.0%
20/80 • Number of events 38
|
|
Nervous system disorders
Hyperaesthesia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Hyperreflexia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
8.4%
8/95 • Number of events 11
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
6.2%
5/80 • Number of events 7
|
|
Nervous system disorders
Hypogeusia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Hyporeflexia
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
6.3%
6/95 • Number of events 8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
7.5%
6/80 • Number of events 8
|
|
Nervous system disorders
Memory impairment
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
8.4%
8/95 • Number of events 13
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
10.0%
8/80 • Number of events 13
|
|
Nervous system disorders
Neuropathy peripheral
|
29.5%
28/95 • Number of events 48
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
30.0%
24/80 • Number of events 42
|
|
Nervous system disorders
Paraesthesia
|
11.6%
11/95 • Number of events 17
|
0.00%
0/3
|
66.7%
2/3 • Number of events 5
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
8.8%
7/80 • Number of events 9
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.8%
15/95 • Number of events 36
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
17.5%
14/80 • Number of events 35
|
|
Nervous system disorders
Presyncope
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 4
|
|
Nervous system disorders
Sensory loss
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Nervous system disorders
Somnolence
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.2%
3/95 • Number of events 4
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Abnormal dreams
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
5.3%
5/95 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
5.0%
4/80 • Number of events 4
|
|
Psychiatric disorders
Confusional state
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Psychiatric disorders
Depression
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
13.7%
13/95 • Number of events 15
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
12.5%
10/80 • Number of events 12
|
|
Psychiatric disorders
Libido decreased
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Nightmare
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/80
|
|
Renal and urinary disorders
Renal impairment
|
3.2%
3/95 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Reproductive system and breast disorders
Genital pain
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular cyst
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular pain
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.1%
21/95 • Number of events 29
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
20.0%
16/80 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
19/95 • Number of events 25
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 5
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
16.2%
13/80 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.3%
6/95 • Number of events 9
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
5.0%
4/80 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.4%
8/95 • Number of events 9
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
10.0%
8/80 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/95 • Number of events 3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.6%
11/95 • Number of events 11
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
11.2%
9/80 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.3%
6/95 • Number of events 7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
7.5%
6/80 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.3%
6/95 • Number of events 7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
3.8%
3/80 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
7/95 • Number of events 7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
6.2%
5/80 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.2%
4/95 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
3.8%
3/80 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/80
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
8/95 • Number of events 9
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
8.8%
7/80 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.7%
13/95 • Number of events 17
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 5
|
13.8%
11/80 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.2%
4/95 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
3.8%
3/80 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.1%
2/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/80
|
|
Vascular disorders
Haematoma
|
2.1%
2/95 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Hot flush
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.2%
3/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
2.5%
2/80 • Number of events 2
|
|
Vascular disorders
Hypotension
|
5.3%
5/95 • Number of events 9
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
6.2%
5/80 • Number of events 9
|
|
Vascular disorders
Orthostatic hypotension
|
2.1%
2/95 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
2.5%
2/80 • Number of events 3
|
|
Vascular disorders
Phlebitis
|
4.2%
4/95 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
2.5%
2/80 • Number of events 3
|
|
Vascular disorders
Thrombophlebitis
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Vascular disorders
Vasculitis
|
1.1%
1/95 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 2
|
|
Vascular disorders
Vein discolouration
|
1.1%
1/95 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
1.2%
1/80 • Number of events 1
|
Additional Information
Senior VP Drug Development
Kyowa Hakko Kirin Pharma, Inc.
Phone: 609-919-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60