Trial Outcomes & Findings for Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma (NCT NCT01478581)
NCT ID: NCT01478581
Last Updated: 2020-03-10
Results Overview
The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
From the date of first study treatment until disease progression per IMWG, up to 60 months
Results posted on
2020-03-10
Participant Flow
Simon 2-stage design . Stage 1 -13 subjects enrolled in cohort 1. For cohort 2,3, and 4, up to 18 subjects were enrolled in Stage 1. Cohort 4 was selected for expansion for enrollment of 43 subjects in Stage 2.
Participant milestones
| Measure |
PCI-32765 420 mg Per Day
PCI-32765 420 mg per day
PCI-32765
|
PCI-32765 560 mg Per Day, 40 mg Dexamethasone
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
PCI-32765 840 mg Per Day
PCI-32765 840 mg per day
PCI-32765
|
PCI-32765 840 mg Per Day, 40 mg Dexamethasone
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
18
|
18
|
43
|
|
Overall Study
COMPLETED
|
13
|
18
|
18
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=18 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 7.57 • n=39 Participants
|
65.5 years
STANDARD_DEVIATION 8.44 • n=41 Participants
|
65.5 years
STANDARD_DEVIATION 7.52 • n=35 Participants
|
65.0 years
STANDARD_DEVIATION 7.40 • n=31 Participants
|
65.0 years
STANDARD_DEVIATION 7.63 • n=146 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
36 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
56 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
82 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · Black or African American
|
2 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
18 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · White
|
10 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
33 Participants
n=31 Participants
|
67 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Other Race · Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=39 Participants
|
18 participants
n=41 Participants
|
18 participants
n=35 Participants
|
43 participants
n=31 Participants
|
92 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: From the date of first study treatment until disease progression per IMWG, up to 60 monthsPopulation: All treated population
The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=18 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
The Clinical Benefit Response (CBR)
|
1 Participants
|
1 Participants
|
0 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From the date of first study treatment until disease progression per IMWG, up to 60 monthsPopulation: All treated population
The objective response rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the modified International Myeloma Working Group (IMWG) response criteria.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=18 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
To Evaluate the Efficacy of PCI-32765 by Assessing ORR
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax)
|
157 ng/mL
Standard Deviation 126
|
103 ng/mL
Standard Deviation 96.7
|
219 ng/mL
Standard Deviation 159
|
166 ng/mL
Standard Deviation 200
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax).
|
2.73 hours
Standard Deviation 1.99
|
2.32 hours
Standard Deviation 1.72
|
1.95 hours
Standard Deviation 0.944
|
2.25 hours
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h).
|
1094 h∙ng/mL
Standard Deviation 808
|
723 h∙ng/mL
Standard Deviation 768
|
1423 h∙ng/mL
Standard Deviation 1014
|
1230 h∙ng/mL
Standard Deviation 1914
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Day 8.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term).
|
7.76 hours
Standard Deviation 1.39
|
6.95 hours
Standard Deviation 0.821
|
8.42 hours
Standard Deviation 2.85
|
6.90 hours
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Acc. Ratio calculated as Day 8 ibrutinib AUC0-24h/ Day 1 ibrutinib AUC0-24h.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Accumulation Ratio for AUC0-24h (Acc. Ratio AUC0-24h)
|
2.75 Ratio
Standard Deviation 3.36
|
1.90 Ratio
Standard Deviation 1.64
|
1.88 Ratio
Standard Deviation 1.41
|
1.31 Ratio
Standard Deviation 0.830
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax)
|
0.952 Ratio
Standard Deviation 0.464
|
1.47 Ratio
Standard Deviation 0.632
|
1.39 Ratio
Standard Deviation 1.36
|
1.39 Ratio
Standard Deviation 0.746
|
SECONDARY outcome
Timeframe: Procedure was performed up to 60 weeks.Population: All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.
Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 AUC0-24h/PCI-45227 molecular weight)/(ibrutinib AUC0-24h/ibrutinib molecular weight) on Day 8.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=16 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 Participants
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for AUC0-24h (M/P AUC0-24h)
|
1.44 Ratio
Standard Deviation 0.567
|
2.21 Ratio
Standard Deviation 0.985
|
1.90 Ratio
Standard Deviation 1.35
|
1.96 Ratio
Standard Deviation 0.923
|
SECONDARY outcome
Timeframe: From the date of first study treatment until disease progression per IMWG, up to 60 monthsPopulation: Clinical benefit responders.
DCB is defined as the time from first observation of response to the time of disease progression.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=1 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=12 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Duration of Clinical Benefit Response (DCB)
|
27.6 Months
Interval 27.6 to 27.6
|
3.7 Months
Interval 3.7 to 3.7
|
—
|
11.5 Months
Interval 2.8 to 46.3
|
SECONDARY outcome
Timeframe: up to 3 YearsPopulation: Responders
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
Outcome measures
| Measure |
Cohort 1
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=1 Participants
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=2 Participants
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
3.7 Month
Interval 3.7 to 3.7
|
—
|
15.4 Month
Interval 3.6 to 27.2
|
Adverse Events
Cohort 1
Serious events: 6 serious events
Other events: 12 other events
Deaths: 2 deaths
Cohort 2
Serious events: 6 serious events
Other events: 18 other events
Deaths: 1 deaths
Cohort 3
Serious events: 7 serious events
Other events: 17 other events
Deaths: 1 deaths
Cohort 4
Serious events: 12 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1
n=13 participants at risk
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=18 participants at risk
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 participants at risk
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 participants at risk
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Infections and infestations
Clostridium difficile infection
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Aspergillus Infection
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Bone Lesion
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Chills
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Device Related Infection
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Vascular disorders
Haematoma
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
General disorders
Hernia Pain
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Herpes Zoster Disseminated
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Lipase Increased
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Small Intestinal Haemorrhage
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Urinary tract Infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
Other adverse events
| Measure |
Cohort 1
n=13 participants at risk
PCI-32765 420 mg per day
PCI-32765
|
Cohort 2
n=18 participants at risk
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
Cohort 3
n=18 participants at risk
PCI-32765 840 mg per day
PCI-32765
|
Cohort 4
n=43 participants at risk
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
PCI-32765
Dexamethasone
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Gastrointestinal disorders
Diarrhoea
|
38.5%
5/13 • Five Years
|
44.4%
8/18 • Five Years
|
55.6%
10/18 • Five Years
|
60.5%
26/43 • Five Years
|
|
General disorders
Fatigue
|
23.1%
3/13 • Five Years
|
38.9%
7/18 • Five Years
|
50.0%
9/18 • Five Years
|
48.8%
21/43 • Five Years
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Five Years
|
27.8%
5/18 • Five Years
|
38.9%
7/18 • Five Years
|
25.6%
11/43 • Five Years
|
|
Blood and lymphatic system disorders
Anemia
|
30.8%
4/13 • Five Years
|
33.3%
6/18 • Five Years
|
33.3%
6/18 • Five Years
|
27.9%
12/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
30.8%
4/13 • Five Years
|
33.3%
6/18 • Five Years
|
16.7%
3/18 • Five Years
|
23.3%
10/43 • Five Years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
38.5%
5/13 • Five Years
|
27.8%
5/18 • Five Years
|
22.2%
4/18 • Five Years
|
20.9%
9/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Five Years
|
16.7%
3/18 • Five Years
|
11.1%
2/18 • Five Years
|
27.9%
12/43 • Five Years
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Five Years
|
27.8%
5/18 • Five Years
|
5.6%
1/18 • Five Years
|
30.2%
13/43 • Five Years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
23.1%
3/13 • Five Years
|
11.1%
2/18 • Five Years
|
38.9%
7/18 • Five Years
|
18.6%
8/43 • Five Years
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Five Years
|
22.2%
4/18 • Five Years
|
11.1%
2/18 • Five Years
|
23.3%
10/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.7%
1/13 • Five Years
|
27.8%
5/18 • Five Years
|
0.00%
0/18 • Five Years
|
25.6%
11/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13 • Five Years
|
27.8%
5/18 • Five Years
|
16.7%
3/18 • Five Years
|
16.3%
7/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
2/13 • Five Years
|
22.2%
4/18 • Five Years
|
11.1%
2/18 • Five Years
|
14.0%
6/43 • Five Years
|
|
General disorders
Pyrexia
|
30.8%
4/13 • Five Years
|
5.6%
1/18 • Five Years
|
16.7%
3/18 • Five Years
|
16.3%
7/43 • Five Years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
15.4%
2/13 • Five Years
|
22.2%
4/18 • Five Years
|
11.1%
2/18 • Five Years
|
14.0%
6/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Five Years
|
22.2%
4/18 • Five Years
|
5.6%
1/18 • Five Years
|
16.3%
7/43 • Five Years
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Five Years
|
22.2%
4/18 • Five Years
|
11.1%
2/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
16.7%
3/18 • Five Years
|
14.0%
6/43 • Five Years
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Five Years
|
11.1%
2/18 • Five Years
|
22.2%
4/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.1%
3/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
General disorders
Oedema Peripheral
|
7.7%
1/13 • Five Years
|
11.1%
2/18 • Five Years
|
16.7%
3/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Five Years
|
5.6%
1/18 • Five Years
|
22.2%
4/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.1%
3/13 • Five Years
|
11.1%
2/18 • Five Years
|
11.1%
2/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
16.3%
7/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
23.1%
3/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.7%
1/13 • Five Years
|
11.1%
2/18 • Five Years
|
11.1%
2/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
16.7%
3/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
General disorders
Asthenia
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
Injury, poisoning and procedural complications
Contusion
|
15.4%
2/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.4%
2/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.4%
2/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
23.1%
3/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Eye disorders
Vision Blurred
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
11.1%
2/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.7%
1/13 • Five Years
|
11.1%
2/18 • Five Years
|
11.1%
2/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
General disorders
Malaise
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
11.1%
2/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.7%
1/13 • Five Years
|
11.1%
2/18 • Five Years
|
11.1%
2/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
11.1%
2/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
15.4%
2/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Infections and infestations
Localised Infection
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
11.1%
2/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.7%
1/13 • Five Years
|
22.2%
4/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
16.7%
3/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.7%
1/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Investigations
Weight Decreased
|
7.7%
1/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Blood and lymphatic system disorders
Bandaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Angina pectoris
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Ear and labyrinth disorders
Ear Congestion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Endocrine disorders
Goitre
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Eye disorders
Eye haemorrhage
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Eye disorders
Eye irritation
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Abnormal sensation in eye
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Asthenopia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Cataract
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Choroidal infarction
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Dry eye
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Eye discharge
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Eye disorders
Eyelid disorder
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Eyelid oedema
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Glaucoma
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Eye disorders
Iritis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Uveitis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Eye disorders
Vitreous floaters
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Melaena
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Oral Discomfort
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Gastrointestinal disorders
Tongue eruption
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Tooth loss
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
General disorders
Chills
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
General disorders
Peripheral swelling
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Chest pain
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Feeling jittery
|
15.4%
2/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
General disorders
Chest discomfort
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Feeling abnormal
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Injection site bruising
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Crepitations
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
General disorders
Facial pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Hernia pain
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Oedema
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
General disorders
Unevaluable event
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Immune system disorders
Food allergy
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Influenza
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Infections and infestations
Paronychia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Infections and infestations
Ear Infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Infections and infestations
Herpes Zoster
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Infections and infestations
Candida infection
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Clostridium difficile infection
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Fungal infection
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Ear infection staphylococcal
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Epididymitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Eye infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Helicobacter infection
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Measles
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Oral herpes
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Otitis externa
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Otitis media
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Systemic candida
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Wound infection
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
11.6%
5/43 • Five Years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Joint injury
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Testicular injury
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Blood lactate dehydrogenase increased
|
15.4%
2/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Blood chloride increased
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Body temperature increased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Cardiac murmur
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Heart rate irregular
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Lymphocyte count increased
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Medical observation abnormal
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Investigations
Neutrophil count increased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
Weight increased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Investigations
White blood cell count increased
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
15.4%
2/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
23.1%
3/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
15.4%
2/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
3/13 • Five Years
|
22.2%
4/18 • Five Years
|
22.2%
4/18 • Five Years
|
18.6%
8/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Muscle oedema
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Nervous system disorders
Disturbance in attention
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Nervous system disorders
Aphasia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Drooling
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Psychiatric disorders
Confusional state
|
7.7%
1/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Psychiatric disorders
Irritability
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Reproductive system and breast disorders
Breast ulceration
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
11.1%
2/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
9.3%
4/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
7.0%
3/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • Five Years
|
11.1%
2/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Nail growth abnormal
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Five Years
|
5.6%
1/18 • Five Years
|
5.6%
1/18 • Five Years
|
4.7%
2/43 • Five Years
|
|
Vascular disorders
Flushing
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Vascular disorders
Haematoma
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Vascular disorders
Hot flush
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
5.6%
1/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Vascular disorders
Pallor
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
7.7%
1/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/43 • Five Years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • Five Years
|
0.00%
0/18 • Five Years
|
0.00%
0/18 • Five Years
|
2.3%
1/43 • Five Years
|
Additional Information
Dr. Bernhard Hauns, Medical Monitor
Pharmacyclics Switzerland GmbH
Phone: +41 52 556 0800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place