Trial Outcomes & Findings for Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans (NCT NCT00541866)
NCT ID: NCT00541866
Last Updated: 2018-01-09
Results Overview
Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (\<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
110 participants
Primary outcome timeframe
From start of treatment (Day 1) through Induction Day 29 or the start of reinduction, whichever occurred first.
Results posted on
2018-01-09
Participant Flow
Conducted in 7 centers in the USA between 2007 and 2010
Dose-escalation phase Group 1 (Sch A, 10 to 90 mg/m2): 41 patients (39 treated) Group 2 (Sch B, 70 to 90 mg/m2): 18 patients Dose-expansion phase Group 3 (Sch A first relapse, 80 mg/m2): 17 patients Group 4 (Sch B first relapse, 90 mg/m2): 16 patients Group 5 (Sch B primary refractory, 90 mg/m2): 18 patients Total: 110. Treated: 108
Participant milestones
| Measure |
Group 1 (Sch A, 10 to 90 mg/m2)
Dose Escalation Phase Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 2 (Sch B, 70 to 90 mg/m2):
Dose Escalation Phase Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 3 (Sch A, First Relapse, 80 mg/m2)
Expansion Phase: Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
|
Group 4 (Sch B, First Relapse, 90 mg/m2)
Expansion Phase: Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
|
Group 5 (Sch B, Primary Refractory, 90 mg/m2)
Expansion Phase Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
18
|
17
|
16
|
18
|
|
Overall Study
COMPLETED
|
7
|
0
|
2
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
34
|
18
|
15
|
16
|
15
|
Reasons for withdrawal
| Measure |
Group 1 (Sch A, 10 to 90 mg/m2)
Dose Escalation Phase Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 2 (Sch B, 70 to 90 mg/m2):
Dose Escalation Phase Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 3 (Sch A, First Relapse, 80 mg/m2)
Expansion Phase: Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
|
Group 4 (Sch B, First Relapse, 90 mg/m2)
Expansion Phase: Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
|
Group 5 (Sch B, Primary Refractory, 90 mg/m2)
Expansion Phase Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
19
|
15
|
10
|
12
|
14
|
|
Overall Study
Not Reported or Other
|
11
|
3
|
3
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans
Baseline characteristics by cohort
| Measure |
Group 1 (Sch A, 10 to 90 mg/m2)
n=39 Participants
Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 2 (Sch B, 70 to 90 mg/m2):
n=18 Participants
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 3 (Sch A, First Relapse, 80 mg/m2):
n=17 Participants
Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 4 (Sch B, First Relapse, 90 mg/m2)
n=16 Participants
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 5 (Sch B, Primary Refractory, 90 mg/m2):
n=18 Participants
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
47.4 Years
STANDARD_DEVIATION 13.83 • n=7 Participants
|
59.7 Years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 11.03 • n=4 Participants
|
56.3 Years
STANDARD_DEVIATION 12.09 • n=21 Participants
|
56.3 Years
STANDARD_DEVIATION 11.95 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
18 participants
n=7 Participants
|
17 participants
n=5 Participants
|
16 participants
n=4 Participants
|
18 participants
n=21 Participants
|
108 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From start of treatment (Day 1) through Induction Day 29 or the start of reinduction, whichever occurred first.Population: Patients experiencing a dose-limiting toxicity (DLT) during induction when treated with escalating doses of vosaroxin administered in combination with cytarabine on Days 1 and 4 in Schedule A, and with vosaroxin in escalating doses administered on Days 1 and 4 in Schedule B.
Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (\<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.
Outcome measures
| Measure |
Sch A, Cohort 10mg/m2
n=4 Participants
Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 20mg/m2
n=3 Participants
Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
SchA, Cohort 34mg/m2
n=4 Participants
Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 50mg/m2
n=6 Participants
Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 70mg/m2
n=7 Participants
Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 80mg/m2
n=8 Participants
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 90mg/m2
n=7 Participants
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 70 mg/m2
n=6 Participants
Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days).
|
Sch B, Cohort 80mg/m2
n=6 Participants
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 90mg/m2
n=6 Participants
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Dose-Limiting Toxicity (DLT) to Determine Maximum Tolerated Dose in Schedule A and Schedule B of Dose Escalation Phase (Group 1 and Group 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Monthly after the end of treatment for the first year, then every 2 months thereafter for upto 2 yearsPopulation: All treated set which includes all enrolled patients who received any IMP.
Complete remission (CR) plus CR with incomplete platelet recovery (CRp) per The IWG criteria for remission modified by Sunesis, assessed by investigator. CR is defined as \>1000 Neutrophils (ul), \>100,000 Platelets (uL) and \<5 BM Blasts (%); CRp is defined as \>1000 Neutrophils (ul), \<=100,000 Platelets (uL) and \<5 BM Blasts (%); CRi is defined as \>1000 Neutrophils (ul), \<100,000 Platelets (uL) and \<5 BM Blasts (%); Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (CR with morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
Outcome measures
| Measure |
Sch A, Cohort 10mg/m2
n=39 Participants
Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 20mg/m2
n=18 Participants
Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
SchA, Cohort 34mg/m2
n=17 Participants
Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 50mg/m2
n=16 Participants
Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 70mg/m2
n=18 Participants
Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 80mg/m2
n=108 Participants
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 70 mg/m2
Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days).
|
Sch B, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Remission Rates (CR+CRp)
|
9 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From time of the start of CR or CRp to the earliest date of relapse, commencement of reinduction therapy, or death, assessed monthly up to 2 years after the end of study visit.Population: All treated analysis set.
Leukemia-free survival is censored at the last known alive date without report of relapse.
Outcome measures
| Measure |
Sch A, Cohort 10mg/m2
n=39 Participants
Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 20mg/m2
n=18 Participants
Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
SchA, Cohort 34mg/m2
n=17 Participants
Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 50mg/m2
n=16 Participants
Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 70mg/m2
n=18 Participants
Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 70 mg/m2
Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days).
|
Sch B, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Leukemia-free Survival (LFS)
|
12.0 months
Interval 4.0 to 32.7
|
4.7 months
Interval 2.3 to 25.2
|
7.4 months
Interval 0.5 to 25.6
|
25.2 months
Interval 2.1 to 26.6
|
NA months
Interval 9.3 to
The median and upper confidence Interval were not available due to insufficient number of participants with events
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time between the date of first study treatment and the date of death due to any cause for upto 2 years after the end of study visitPopulation: All treated analysis set
Overall survival is censored at the earlier of the cutoff date for analysis and the last date known to be alive for patients not known to have died.
Outcome measures
| Measure |
Sch A, Cohort 10mg/m2
n=39 Participants
Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 20mg/m2
n=18 Participants
Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
SchA, Cohort 34mg/m2
n=17 Participants
Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 50mg/m2
n=16 Participants
Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 70mg/m2
n=18 Participants
Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 70 mg/m2
Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days).
|
Sch B, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
4.1 months
Interval 2.5 to 8.5
|
8.0 months
Interval 3.3 to 13.3
|
4.1 months
Interval 2.5 to 11.8
|
7.1 months
Interval 4.3 to 13.6
|
5.9 months
Interval 2.9 to 16.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 and 60 daysPopulation: All treated analysis set
Mortality of those patients enrolled in the study and receiving intervention
Outcome measures
| Measure |
Sch A, Cohort 10mg/m2
n=39 Participants
Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 20mg/m2
n=18 Participants
Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
SchA, Cohort 34mg/m2
n=17 Participants
Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 50mg/m2
n=16 Participants
Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 70mg/m2
n=18 Participants
Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch A, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 70 mg/m2
Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days).
|
Sch B, Cohort 80mg/m2
Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Sch B, Cohort 90mg/m2
Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
All Cause Mortality
30 Days
|
8 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
All Cause Mortality
60 Days
|
10 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1 (Sch A, 10 to 90 mg/m2):
Serious events: 20 serious events
Other events: 39 other events
Deaths: 36 deaths
Group 2 (Sch B, 70 to 90 mg/m2):
Serious events: 7 serious events
Other events: 18 other events
Deaths: 16 deaths
Group 3 (Sch A, First Relapse, 80 mg/m2)
Serious events: 9 serious events
Other events: 17 other events
Deaths: 15 deaths
Group 4 (Sch B, First Relapse, 90 mg/m2):
Serious events: 3 serious events
Other events: 16 other events
Deaths: 14 deaths
Group 5 (Sch B, Primary Refractory, 90 mg/m2):
Serious events: 11 serious events
Other events: 18 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Group 1 (Sch A, 10 to 90 mg/m2):
n=39 participants at risk
Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 2 (Sch B, 70 to 90 mg/m2):
n=18 participants at risk
saroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 3 (Sch A, First Relapse, 80 mg/m2)
n=17 participants at risk
Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 4 (Sch B, First Relapse, 90 mg/m2):
n=16 participants at risk
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 5 (Sch B, Primary Refractory, 90 mg/m2):
n=18 participants at risk
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.3%
4/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oesophagitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oral soft tissue disorder
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Multi-organ failure
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Bacteraemia
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Chronic sinusitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Clostridium difficile colitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Enterobacter bacteraemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Enterococcal bacteraemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Enterococcal sepsis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Escherichia bacteraemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Pneumonia
|
5.1%
2/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Pneumonia fungal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Infections and infestations
Septic shock
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Streptococcal bacteraemia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Nervous system disorders
Migraine
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Hypertensive crisis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
Other adverse events
| Measure |
Group 1 (Sch A, 10 to 90 mg/m2):
n=39 participants at risk
Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 2 (Sch B, 70 to 90 mg/m2):
n=18 participants at risk
saroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 3 (Sch A, First Relapse, 80 mg/m2)
n=17 participants at risk
Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV \[CIV\] infusion of 400 mg/m2/day × 5 days)
|
Group 4 (Sch B, First Relapse, 90 mg/m2):
n=16 participants at risk
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
Group 5 (Sch B, Primary Refractory, 90 mg/m2):
n=18 participants at risk
Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)
|
|---|---|---|---|---|---|
|
Vascular disorders
Haematoma
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Vascular calcification
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
3/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Surgical and medical procedures
Post procedural drainage
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Flushing
|
15.4%
6/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Vascular disorders
Hypertension
|
20.5%
8/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Vascular disorders
Hypotension
|
43.6%
17/39 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
41.2%
7/17 • 4 years, 4 months
|
43.8%
7/16 • 4 years, 4 months
|
38.9%
7/18 • 4 years, 4 months
|
|
Vascular disorders
Jugular vein distension
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Orthostatic hypotension
|
12.8%
5/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Vasculitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Staphylococcal infection
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Stenotrophomonas infection
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Subcutaneous abscess
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Torulopsis infection
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
3/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.4%
6/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
31.2%
5/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Scratch
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Anaemia
|
48.7%
19/39 • 4 years, 4 months
|
61.1%
11/18 • 4 years, 4 months
|
47.1%
8/17 • 4 years, 4 months
|
68.8%
11/16 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
53.8%
21/39 • 4 years, 4 months
|
66.7%
12/18 • 4 years, 4 months
|
47.1%
8/17 • 4 years, 4 months
|
62.5%
10/16 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.1%
2/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
6/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
37.5%
6/16 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Splenic infarction
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
43.6%
17/39 • 4 years, 4 months
|
50.0%
9/18 • 4 years, 4 months
|
41.2%
7/17 • 4 years, 4 months
|
56.2%
9/16 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
|
Cardiac disorders
Arrhythmia supraventricular
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Atrial tachycardia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Bradycardia
|
17.9%
7/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Intracardiac mass
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Cardiac disorders
Pericardial effusion
|
2.6%
1/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Sinus tachycardia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Tachycardia
|
28.2%
11/39 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Auricular swelling
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Ear disorder
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Ear pain
|
12.8%
5/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Mastoid disorder
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Conjunctival hyperaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Eye disorders
Diplopia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Eye disorders
Dry eye
|
5.1%
2/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Eye irritation
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Eye pain
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Eye swelling
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Eye disorders
Meibomianitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Ocular icterus
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Eye disorders
Orbital oedema
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Papilloedema
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Photophobia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Photopsia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Pupil fixed
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Scleral haemorrhage
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Vision blurred
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Visual acuity reduced
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Visual disturbance
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal distension
|
28.2%
11/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
38.5%
15/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Abdominal tenderness
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Anal discomfort
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Ascites
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Caecitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Cheilitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Colitis
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Colonic polyp
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
38.5%
15/39 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
47.1%
8/17 • 4 years, 4 months
|
37.5%
6/16 • 4 years, 4 months
|
38.9%
7/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
71.8%
28/39 • 4 years, 4 months
|
72.2%
13/18 • 4 years, 4 months
|
88.2%
15/17 • 4 years, 4 months
|
75.0%
12/16 • 4 years, 4 months
|
66.7%
12/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Diverticulum
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
4/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
3/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
35.3%
6/17 • 4 years, 4 months
|
25.0%
4/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
2/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Enteritis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Faecal incontinence
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Faeces hard
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
3/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gingival pain
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Gingivitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Haematemesis
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Haematochezia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
3/39 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lip dry
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lip pain
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Melaena
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
74.4%
29/39 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
82.4%
14/17 • 4 years, 4 months
|
62.5%
10/16 • 4 years, 4 months
|
66.7%
12/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Odynophagia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oesophagitis
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Oral soft tissue disorder
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Peritonitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Proctalgia
|
10.3%
4/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Stomach discomfort
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
53.8%
21/39 • 4 years, 4 months
|
72.2%
13/18 • 4 years, 4 months
|
64.7%
11/17 • 4 years, 4 months
|
93.8%
15/16 • 4 years, 4 months
|
55.6%
10/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Tongue coated
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Tongue ulceration
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
53.8%
21/39 • 4 years, 4 months
|
38.9%
7/18 • 4 years, 4 months
|
64.7%
11/17 • 4 years, 4 months
|
25.0%
4/16 • 4 years, 4 months
|
50.0%
9/18 • 4 years, 4 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Application site pruritus
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Application site vesicles
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Asthenia
|
28.2%
11/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
47.1%
8/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
|
General disorders
Axillary pain
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Catheter related complication
|
2.6%
1/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
31.2%
5/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
General disorders
Catheter site erythema
|
10.3%
4/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Catheter site excoriation
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Catheter site haemorrhage
|
7.7%
3/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Catheter site oedema
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Catheter site pain
|
10.3%
4/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Catheter site pruritus
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Catheter site rash
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Catheter site related reaction
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Chest discomfort
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Chest pain
|
10.3%
4/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
General disorders
Chills
|
46.2%
18/39 • 4 years, 4 months
|
44.4%
8/18 • 4 years, 4 months
|
47.1%
8/17 • 4 years, 4 months
|
37.5%
6/16 • 4 years, 4 months
|
38.9%
7/18 • 4 years, 4 months
|
|
General disorders
Face oedema
|
10.3%
4/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
General disorders
Facial pain
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Fatigue
|
41.0%
16/39 • 4 years, 4 months
|
38.9%
7/18 • 4 years, 4 months
|
41.2%
7/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
50.0%
9/18 • 4 years, 4 months
|
|
General disorders
Feeling cold
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Gait disturbance
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Generalised oedema
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Hypothermia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Infusion site pain
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Infusion site reaction
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Infusion site vesicles
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Infusion site warmth
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Injection site pain
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Localised oedema
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Malaise
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Nodule
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Non-cardiac chest pain
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Oedema
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
General disorders
Oedema peripheral
|
43.6%
17/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
41.2%
7/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
50.0%
9/18 • 4 years, 4 months
|
|
General disorders
Pain
|
12.8%
5/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
25.0%
4/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
General disorders
Performance status decreased
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Pyrexia
|
33.3%
13/39 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
General disorders
Sensation of foreign body
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Suprapubic pain
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Tenderness
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
General disorders
Thirst
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
General disorders
Upper extremity mass
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Dilatation intrahepatic duct acquired
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Hepatobiliary disorders
Jaundice
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Immune system disorders
Drug hypersensitivity
|
12.8%
5/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Acute sinusitis
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Anorectal infection bacterial
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Bacteraemia
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Bacterial infection
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Bronchiolitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Candidiasis
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Cellulitis
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Clostridial infection
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Clostridium difficile colitis
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Enterococcal bacteraemia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Enterococcal sepsis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Fungaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Furuncle
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Liver abscess
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Oral candidiasis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Infections and infestations
Oral herpes
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Parotitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Perianal abscess
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Pneumonia
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Pneumonia fungal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Rectal abscess
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Rhinitis
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Septic shock
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Sialoadenitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Sinusitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
5.1%
2/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Bacteria sputum identified
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Bacteria stool identified
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Bacteria urine identified
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood alkaline phosphatase increased
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood bilirubin increased
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood creatinine increased
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood urea increased
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Blood urine present
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Breath sounds abnormal
|
23.1%
9/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Investigations
Bronchoscopy abnormal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Cardiac murmur
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Investigations
Computerised tomogram abdomen abnormal
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Computerised tomogram abnormal
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Culture stool positive
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Ejection fraction decreased
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Heart rate irregular
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Heart sounds abnormal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
International normalised ratio increased
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Liver function test abnormal
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Methicillin-resistant staphylococcal aureus test positive
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Occult blood
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Oxygen saturation decreased
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Ultrasound kidney
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Urine output decreased
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Varicella zoster virus serology positive
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Investigations
Weight decreased
|
10.3%
4/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Investigations
Weight increased
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
12/39 • 4 years, 4 months
|
61.1%
11/18 • 4 years, 4 months
|
76.5%
13/17 • 4 years, 4 months
|
31.2%
5/16 • 4 years, 4 months
|
55.6%
10/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Cachexia
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
9/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
10.3%
4/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Gout
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.5%
8/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.1%
2/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.3%
4/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
76.9%
30/39 • 4 years, 4 months
|
55.6%
10/18 • 4 years, 4 months
|
88.2%
15/17 • 4 years, 4 months
|
56.2%
9/16 • 4 years, 4 months
|
83.3%
15/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
46.2%
18/39 • 4 years, 4 months
|
55.6%
10/18 • 4 years, 4 months
|
76.5%
13/17 • 4 years, 4 months
|
43.8%
7/16 • 4 years, 4 months
|
55.6%
10/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
28.2%
11/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
52.9%
9/17 • 4 years, 4 months
|
31.2%
5/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
7/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
41.0%
16/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.6%
1/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
4/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.1%
2/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
2/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Nodule on extremity
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.6%
10/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Ageusia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Brain oedema
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Burning sensation
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
43.8%
7/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Nervous system disorders
Dysaesthesia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Dysarthria
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Nervous system disorders
Dysgeusia
|
12.8%
5/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
|
Nervous system disorders
Encephalopathy
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Facial palsy
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Headache
|
35.9%
14/39 • 4 years, 4 months
|
38.9%
7/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
43.8%
7/16 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
3/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Hyposmia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Lethargy
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Neuropathy peripheral
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Paraesthesia
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Nervous system disorders
Parosmia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Nervous system disorders
Psychomotor hyperactivity
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Restless legs syndrome
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Somnolence
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Transient ischaemic attack
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Agitation
|
17.9%
7/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Anxiety
|
28.2%
11/39 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
35.3%
6/17 • 4 years, 4 months
|
31.2%
5/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Psychiatric disorders
Bradyphrenia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Confusional state
|
15.4%
6/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Psychiatric disorders
Delirium
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Depressed mood
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Depression
|
15.4%
6/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
29.4%
5/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Psychiatric disorders
Hallucination
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Hallucination, visual
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Insomnia
|
35.9%
14/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
52.9%
9/17 • 4 years, 4 months
|
37.5%
6/16 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
|
Psychiatric disorders
Mental status changes
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Nervousness
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Nightmare
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Psychiatric disorders
Restlessness
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Azotaemia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Haematuria
|
10.3%
4/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Nocturia
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Pollakiuria
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Renal failure acute
|
10.3%
4/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Urethral pain
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Urinary hesitation
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Urinary incontinence
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Reproductive system and breast disorders
Epididymitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Reproductive system and breast disorders
Scrotal irritation
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Reproductive system and breast disorders
Testicular swelling
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Reproductive system and breast disorders
Vaginal laceration
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.5%
8/39 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
25.0%
4/16 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.8%
12/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
33.3%
6/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.3%
4/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
9/39 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
23.5%
4/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
3/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
41.2%
7/17 • 4 years, 4 months
|
25.0%
4/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.1%
2/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.8%
5/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.3%
4/39 • 4 years, 4 months
|
27.8%
5/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.1%
2/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
17.9%
7/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.3%
4/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.5%
8/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
29.4%
5/17 • 4 years, 4 months
|
37.5%
6/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
4/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.7%
3/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.3%
4/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
12.5%
2/16 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
0.00%
0/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
15.4%
6/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
2.6%
1/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
15.4%
6/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
5.1%
2/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.1%
2/39 • 4 years, 4 months
|
22.2%
4/18 • 4 years, 4 months
|
11.8%
2/17 • 4 years, 4 months
|
25.0%
4/16 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
9/39 • 4 years, 4 months
|
11.1%
2/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
12/39 • 4 years, 4 months
|
16.7%
3/18 • 4 years, 4 months
|
41.2%
7/17 • 4 years, 4 months
|
18.8%
3/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
17.6%
3/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
2/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
5.9%
1/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.7%
3/39 • 4 years, 4 months
|
5.6%
1/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
6.2%
1/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.6%
1/39 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
0.00%
0/17 • 4 years, 4 months
|
0.00%
0/16 • 4 years, 4 months
|
0.00%
0/18 • 4 years, 4 months
|
Additional Information
Mike Johnston, Senior Director Regulatory Affairs
Sunesis Pharmaceuticals, Inc.
Phone: (650) 266-3727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60