A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00621244
Collaborator
(none)
175
7
4
81.1
25
0.3

Study Details

Study Description

Brief Summary

This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies
Actual Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Dec 3, 2009
Actual Study Completion Date :
Dec 3, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1, Group X

Drug: LBH589

Experimental: Arm 1, Group Y

Drug: LBH589

Experimental: Arm 2, Group X

Drug: LBH589

Experimental: Arm 2, Group Y

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

Drug: LBH589

Outcome Measures

Primary Outcome Measures

  1. Number of Participants DLT in Arm 1 in Dose Escalation Phase [Cycle 1 (28-day treatment cycle)]

    Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.

  2. Number of Participants DLT in Arm 2 in Dose Escalation Phase [Cycle 1 (28-day treamtent cycle)]

    Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.

Secondary Outcome Measures

  1. Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) [3.5 years]

    Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.

  2. Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase [1.2 years]

    Stage 2 did not open for enrollment.

  3. Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) [3.5 years]

    Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.

  4. Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) [3.5 years]

    Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.

  5. Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 [Day 1]

  6. Half Life of Panobinostat After the First Dose in Arms 1 and 2 [Day 1]

  7. Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 [Day 15]

    From day 15 by dose with schedule: MWF every week

  8. Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 [Day 15]

  9. Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 [Day 15/day 1]

    MWF Every week schedule n = number of subjects with non-missing values.

  10. Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X [Days 1, 5, 8, 10, 15]

    Reporting the number of patients with a reading at the timepoint in the dose group.

  11. Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y [Days 5, 8, end of study (up to 3.5 years)]

  12. Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X [Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)]

  13. Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y [Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)]

  14. Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) [Post dose to pre-dose (up to 3.5 years)]

    All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))

  15. Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) [Post dose to pre-dose (up to 3.5 years)]

    All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
  • Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy

  • World Health Organization (WHO) performance status ≤ 2

  • Patients who met protocol-specified hematologic and non-hematologic laboratory values

  • Patients with adequate liver and renal function

Exclusion criteria:
  • Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid

  • Peripheral neuropathy ≥ CTCAE grade 2

  • Unresolved diarrhea ≥ CTCAE grade 2

  • Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589

  • Female patients who were pregnant or breast feeding

  • Patients who were unwilling to use an effective method of birth control

  • Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589

  • Patients with another primary malignancy that required active intervention or were clinically significant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia Augusta Georgia United States 30912
2 Dana Farber Cancer Institute Boston Massachusetts United States 02115
3 MD Anderson Cancer Center/University of Texas Houston Texas United States 77030
4 Novartis Investigative Site Parkville Victoria Australia 3002
5 Novartis Investigative Site Prahran Victoria Australia 3181
6 Novartis Investigative Site Frankfurt/M Germany 60590
7 Novartis Investigative Site Mainz Germany 55131

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00621244
Other Study ID Numbers:
  • CLBH589B2102
  • 2005-003670-26
First Posted:
Feb 22, 2008
Last Update Posted:
Jan 5, 2021
Last Verified:
Jul 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Arm 1, Group X Arm 1, Group Y Arm 2, Group X Arm 2, Group Y
Arm/Group Description panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
Period Title: Overall Study
STARTED 86 34 33 23
COMPLETED 0 0 0 0
NOT COMPLETED 86 34 33 23

Baseline Characteristics

Arm/Group Title Arm 1, Group X Arm 1, Group Y Arm 2, Group X Arm 2, Group Y Total
Arm/Group Description panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. Total of all reporting groups
Overall Participants 86 34 33 23 176
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
64.2
(12.11)
41.1
(17.27)
68.7
(8.75)
48.3
(17.41)
58.5
(16.97)
Sex: Female, Male (Count of Participants)
Female
31
36%
13
38.2%
12
36.4%
5
21.7%
61
34.7%
Male
55
64%
21
61.8%
21
63.6%
18
78.3%
115
65.3%

Outcome Measures

1. Primary Outcome
Title Number of Participants DLT in Arm 1 in Dose Escalation Phase
Description Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Time Frame Cycle 1 (28-day treatment cycle)

Outcome Measure Data

Analysis Population Description
MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.
Arm/Group Title Arm 1, Group X (20 mg) Arm 1, Group X (30 mg) Arm 1, Group X (40 mg) Arm 1, Group X (60 mg) - MTD Arm 1, Group X (80 mg) Arm 1, Group Y (20 mg) Arm 1, Group Y (30 mg) Arm 1, Group Y (40 mg) - MTD Arm 1, Group Y (60 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
Measure Participants 7 6 8 12 6 1 3 15 4
Number [Participants]
0
0%
0
0%
2
6.1%
1
4.3%
4
2.3%
0
NaN
0
NaN
5
NaN
4
NaN
2. Primary Outcome
Title Number of Participants DLT in Arm 2 in Dose Escalation Phase
Description Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Time Frame Cycle 1 (28-day treamtent cycle)

Outcome Measure Data

Analysis Population Description
MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.
Arm/Group Title Arm 2, Group X (30 mg) Arm 2, Group X (45 mg) Arm 2, Group X (60 mg) Arm 2, Group X (80 mg) Arm 2, Group Y (30 mg) Arm 2, Group Y (45 mg) Arm 2, Group Y (60 mg) - MTD
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
Measure Participants 6 7 7 8 1 6 13
Number [Participants]
0
0%
0
0%
0
0%
4
17.4%
0
0%
0
NaN
3
NaN
3. Secondary Outcome
Title Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Description Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
Time Frame 3.5 years

Outcome Measure Data

Analysis Population Description
Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.
Arm/Group Title Arm 1, Group X Arm 2, Group X
Arm/Group Description panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
Measure Participants 59 24
Complete response (CR)
2
2.3%
0
0%
Partial remission (PR)
1
1.2%
1
2.9%
Stable disease (SD)
25
29.1%
10
29.4%
Progressive disease (PD)/failure
17
19.8%
4
11.8%
Not evaluable
3
3.5%
1
2.9%
Missing
11
12.8%
8
23.5%
4. Secondary Outcome
Title Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Description Stage 2 did not open for enrollment.
Time Frame 1.2 years

Outcome Measure Data

Analysis Population Description
Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.
Arm/Group Title Arm 1, Group X
Arm/Group Description panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
Measure Participants 19
Complete response (CR)
1
1.2%
Progressive disease (PD)/failure
5
5.8%
Stable disease (SD)
6
7%
Not evaluable
2
2.3%
Missing
5
5.8%
5. Secondary Outcome
Title Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Description Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
Time Frame 3.5 years

Outcome Measure Data

Analysis Population Description
Full Analysis Set
Arm/Group Title Arm 1, Group Y Arm 2, Group Y
Arm/Group Description panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
Measure Participants 22 10
Complete response (CR)
1
1.2%
1
2.9%
Partial remission (PR)
4
4.7%
3
8.8%
Stable disease (SD)
11
12.8%
4
11.8%
Progressive disease (PD)/failure
1
1.2%
2
5.9%
Missing
5
5.8%
0
0%
6. Secondary Outcome
Title Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Description Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
Time Frame 3.5 years

Outcome Measure Data

Analysis Population Description
Full Analysis Set
Arm/Group Title Arm 1, Group X Arm 2, Group X
Arm/Group Description panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
Measure Participants 9 2
Complete response (CR)
0
0%
0
0%
Stable disease (SD)
4
4.7%
1
2.9%
Progressive disease (PD)/failure
4
4.7%
0
0%
Missing
1
1.2%
0
0%
Partial remission (PR)
0
0%
1
2.9%
7. Secondary Outcome
Title Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
Description
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample.
Arm/Group Title 20 mg 30 mg 40 mg 45 mg 60 mg 80 mg
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 9 18 24 15 53 18
Mean (Standard Deviation) [ng/mL]
19.5
(11.84)
39.8
(27.51)
58
(34.25)
54
(28.38)
66.9
(46.55)
63.5
(36.6)
8. Secondary Outcome
Title Half Life of Panobinostat After the First Dose in Arms 1 and 2
Description
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
Pharmacokinetic set
Arm/Group Title 20 mg 30 mg 40 mg 45 mg 60 mg 80 mg
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 9 18 24 15 53 18
Mean (Standard Deviation) [hour]
13.8
(6.65)
18.2
(5.47)
13.6
(3.26)
19.7
(11.68)
15.4
(4.14)
14.6
(2.6)
9. Secondary Outcome
Title Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
Description From day 15 by dose with schedule: MWF every week
Time Frame Day 15

Outcome Measure Data

Analysis Population Description
Pharmacokinetic set
Arm/Group Title 20 mg 30 mg 40 mg 60 mg 80 mg
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 8 12 22 17 4
Mean (Standard Deviation) [ng/mL]
33.6
(16.33)
38.4
(23.58)
41.6
(36.54)
51.8
(28.78)
69.6
(26.78)
10. Secondary Outcome
Title Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
Description
Time Frame Day 15

Outcome Measure Data

Analysis Population Description
Pharmacokinetic set
Arm/Group Title 20 mg 30 mg 40 mg 60 mg 80 mg
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 8 12 22 17 4
Mean (Standard Deviation) [hour]
20.1
(7.06)
19.7
(6.03)
21.4
(8.87)
17.9
(4.61)
17.7
(8.9)
11. Secondary Outcome
Title Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
Description MWF Every week schedule n = number of subjects with non-missing values.
Time Frame Day 15/day 1

Outcome Measure Data

Analysis Population Description
Pharmacokinetic set
Arm/Group Title 20 mg 30 mg 40 mg 60 mg 80 mg
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 8 12 18 17 4
AUC
2.16
1.07
0.98
1.17
1.12
C (max) N=8,12,18,17,4
1.86
1.02
0.63
0.74
1.41
12. Secondary Outcome
Title Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Description Reporting the number of patients with a reading at the timepoint in the dose group.
Time Frame Days 1, 5, 8, 10, 15

Outcome Measure Data

Analysis Population Description
Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group.
Arm/Group Title Arm 1, Group X (20 mg) Arm 1, Group X (30 mg) Arm 1, Group X (40 mg) Arm 1, Group X (60 mg) Arm 1, Group X (80 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
Measure Participants 8 8 10 49 11
Day 1 (total=0, 1, 0, 0, 0)
NA
NaN
100.0
294.1%
NA
NaN
NA
NaN
NA
NaN
Day 5 (total = 6, 4, 8, 17, 8)
100.0
116.3%
75.0
220.6%
87.5
265.2%
82.4
358.3%
37.5
21.3%
Day 8 (total = 5, 4, 8, 17, 7)
100.0
116.3%
100.0
294.1%
75.0
227.3%
82.4
358.3%
57.1
32.4%
Day 10 (total=0, 0, 0, 0, 0, 1)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
100.0
56.8%
Day 15 (total=3, 3, 4, 2, 2)
66.7
77.6%
33.3
97.9%
50.0
151.5%
50.0
217.4%
50.0
28.4%
13. Secondary Outcome
Title Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Description
Time Frame Days 5, 8, end of study (up to 3.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set
Arm/Group Title Arm 1, Group Y (20 mg) Arm 1, Group Y (30 mg) Arm 1, Group Y (40 mg) Arm 1, Group Y (60 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 1 4 24 5
Day 5 (total= 1, 2, 15, 4)
100.0
116.3%
100.0
294.1%
66.7
202.1%
75.0
326.1%
Day 8 (total = 1, 3, 11, 4)
100.0
116.3%
100.0
294.1%
72.7
220.3%
75.0
326.1%
End of Study (total=1, 0, 0, 0)
0.0
0%
NA
NaN
NA
NaN
NA
NaN
14. Secondary Outcome
Title Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Description
Time Frame Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set
Arm/Group Title Arm 2, Group X (30 mg) Arm 2, Group X (45 mg) Arm 2, Group X (60 mg) Arm 2, Group X (80 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 6 9 9 9
Day 5 (total=4, 9, 6, 8)
50.0
58.1%
88.9
261.5%
83.3
252.4%
100.0
434.8%
Day 8 (total = 4, 7, 5, 7)
50.0
58.1%
100.0
294.1%
80.0
242.4%
100.0
434.8%
Day 10 (Total=3, 8, 5, 7)
33.3
38.7%
37.5
110.3%
80.0
242.4%
100.0
434.8%
Day 12 (Total=4, 6, 4, 8)
25.0
29.1%
NA
NaN
50.0
151.5%
50.0
217.4%
Day 15 (Total=4, 6, 2, 5)
75.0
87.2%
50.0
147.1%
100.0
303%
60.0
260.9%
End of Study (Total=1, 4, 2, 0)
100.0
116.3%
75.0
220.6%
50.0
151.5%
0.0
0%
Unscheduled (Total=2, 0, 0, 0)
50.0
58.1%
NA
NaN
NA
NaN
NA
NaN
15. Secondary Outcome
Title Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Description
Time Frame Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set
Arm/Group Title Arm 2, Group Y (30 mg) Arm 2, Group Y (45 mg) Arm 2, Group Y (60 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF) Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
Measure Participants 1 7 15
Day 5 (total=1, 4, 6)
100.0
116.3%
100.0
294.1%
100.0
303%
Day 8 (total = 1, 4, 6)
100.0
116.3%
100.0
294.1%
83.3
252.4%
Day 10 (total=1, 4, 5)
NA
NaN
50.0
147.1%
60.0
181.8%
Day 12 (Total=0, 3, 5)
NA
NaN
33.3
97.9%
40.0
121.2%
Day 15 (Total=1, 3, 5)
100.0
116.3%
33.3
97.9%
0
0%
End of Study (Total=0, 2, 0)
NA
NaN
50.0
147.1%
NA
NaN
16. Secondary Outcome
Title Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
Description All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Time Frame Post dose to pre-dose (up to 3.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (with available samples for analysis)
Arm/Group Title Arm 1, Group X (20 mg) Arm 1, Group x (30 mg) Arm 1, Group X (40 mg) Arm 1, Group X (60 mg) Arm 1, Group X (80 mg) Arm 1, Group Y (20 mg) Arm 1, Group Y (30 mg) Arm 1, Group Y (40mg) Arm 1, Group Y (60 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
Measure Participants 8 4 7 21 8 1 4 16 5
Mean (Standard Deviation) [Percent Change]
56.6
(97.26)
22.5
(45)
63.2
(87.21)
591.4
(2438.34)
31
(70.04)
66.7
(NA)
150.0
(125.59)
196.3
(193.25)
1998.5
(4250.04)
17. Secondary Outcome
Title Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
Description All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Time Frame Post dose to pre-dose (up to 3.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (with available samples for analysis)
Arm/Group Title Arm 2, Group X (30 mg) Arm 2, Group X (45 mg) Arm 2, Group X (60 mg) Arm 2, Group X (80 mg) Arm 2, Group Y (30 mg) Arm 2, Group Y (45 mg) Arm 2, Group Y (60 mg)
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
Measure Participants 3 8 7 6 1 4 10
Mean (Standard Deviation) [Percent Change]
96.2
(103.01)
67.7
(131.87)
59.3
(125.18)
34.2
(47.88)
0.0
(NA)
200.7
(210.73)
376.0
(540.27)

Adverse Events

Time Frame AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
Adverse Event Reporting Description
Arm/Group Title Arm1, Group X (20 mg) Arm1, Group X (30 mg) Arm1, Group X (40 mg) Arm1 GroupX 60 mg Arm1 GroupX 80 mg Arm1 GroupY 20 mg Arm1 GroupY 30 mg Arm1 GroupY 40 mg Arm1 GroupY 60 mg Arm2 GroupX 30 mg Arm2 GroupX 45 mg Arm2 GroupX 60 mg Arm2 GroupX 80 mg Arm2 GroupY 30 mg Arm2 GroupY 45 mg Arm2 GroupY 60 mg
Arm/Group Description Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
All Cause Mortality
Arm1, Group X (20 mg) Arm1, Group X (30 mg) Arm1, Group X (40 mg) Arm1 GroupX 60 mg Arm1 GroupX 80 mg Arm1 GroupY 20 mg Arm1 GroupY 30 mg Arm1 GroupY 40 mg Arm1 GroupY 60 mg Arm2 GroupX 30 mg Arm2 GroupX 45 mg Arm2 GroupX 60 mg Arm2 GroupX 80 mg Arm2 GroupY 30 mg Arm2 GroupY 45 mg Arm2 GroupY 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Arm1, Group X (20 mg) Arm1, Group X (30 mg) Arm1, Group X (40 mg) Arm1 GroupX 60 mg Arm1 GroupX 80 mg Arm1 GroupY 20 mg Arm1 GroupY 30 mg Arm1 GroupY 40 mg Arm1 GroupY 60 mg Arm2 GroupX 30 mg Arm2 GroupX 45 mg Arm2 GroupX 60 mg Arm2 GroupX 80 mg Arm2 GroupY 30 mg Arm2 GroupY 45 mg Arm2 GroupY 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 8/8 (100%) 5/8 (62.5%) 9/10 (90%) 34/49 (69.4%) 10/11 (90.9%) 0/1 (0%) 3/4 (75%) 10/24 (41.7%) 2/5 (40%) 5/6 (83.3%) 8/9 (88.9%) 7/9 (77.8%) 8/9 (88.9%) 0/1 (0%) 3/7 (42.9%) 11/15 (73.3%)
Blood and lymphatic system disorders
Anaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 2/4 (50%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Febrile neutropenia 4/8 (50%) 0/8 (0%) 4/10 (40%) 12/49 (24.5%) 4/11 (36.4%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 2/5 (40%) 2/6 (33.3%) 3/9 (33.3%) 3/9 (33.3%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Leukocytosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Neutropenia 0/8 (0%) 1/8 (12.5%) 1/10 (10%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Thrombocytopenia 0/8 (0%) 1/8 (12.5%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 2/9 (22.2%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cardiac disorders
Acute myocardial infarction 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Atrial fibrillation 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Atrial flutter 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cardiac failure 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Cardiac failure congestive 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Cardiomyopathy 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sinus tachycardia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Supraventricular tachycardia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tachycardia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Ear and labyrinth disorders
Vertigo positional 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gastrointestinal disorders
Abdominal distension 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Abdominal pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Abdominal pain upper 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Constipation 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Diarrhoea 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Diarrhoea haemorrhagic 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Femoral hernia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gastritis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Nausea 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pancreatitis acute 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Rectal haemorrhage 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Umbilical hernia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vomiting 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
General disorders
Catheter related complication 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Chest pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Condition aggravated 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Disease progression 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fatigue 3/8 (37.5%) 0/8 (0%) 4/10 (40%) 3/49 (6.1%) 3/11 (27.3%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
General physical health deterioration 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Generalised oedema 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Multi-organ failure 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pyrexia 0/8 (0%) 0/8 (0%) 2/10 (20%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 2/24 (8.3%) 0/5 (0%) 1/6 (16.7%) 2/9 (22.2%) 1/9 (11.1%) 3/9 (33.3%) 0/1 (0%) 1/7 (14.3%) 3/15 (20%)
Hepatobiliary disorders
Bile duct stone 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cholangitis 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cholecystitis acute 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperbilirubinaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Infections and infestations
Alpha haemolytic streptococcal infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Arthritis viral 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Bacteraemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bacterial infection 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bacterial sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bronchopulmonary aspergillosis 2/8 (25%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Catheter related infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Catheter sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Cellulitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Clostridium difficile colitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Enterococcal sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Escherichia infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gastroenteritis 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Influenza 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lower respiratory tract infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Necrotising fasciitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Neutropenic infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Neutropenic sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Penile abscess 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Perirectal abscess 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pharyngitis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pneumonia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 4/49 (8.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Pneumonia fungal 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pseudomonas infection 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sepsis 1/8 (12.5%) 1/8 (12.5%) 0/10 (0%) 4/49 (8.2%) 1/11 (9.1%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 1/5 (20%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Septic shock 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Serratia infection 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sinusitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Staphylococcal bacteraemia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Staphylococcal infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Urinary tract infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Injury, poisoning and procedural complications
Drug toxicity 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hip fracture 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Lower limb fracture 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Meniscus lesion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Transfusion reaction 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Transfusion-related circulatory overload 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Investigations
Blood creatinine increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cardiac electrophysiologic study abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrocardiogram T wave abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lipase increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Liver function test abnormal 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Troponin I increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Troponin increased 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Metabolism and nutrition disorders
Anorexia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dehydration 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Failure to thrive 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fluid imbalance 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperuricaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypokalaemia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyponatraemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Arthritis reactive 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Back pain 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bone pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Chondrocalcinosis pyrophosphate 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Musculoskeletal pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Myofascitis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Leukaemic infiltration brain 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Leukostasis 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Squamous cell carcinoma of skin 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tumour lysis syndrome 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 2/9 (22.2%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Nervous system disorders
Cerebral haemorrhage 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cerebral ischaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cerebrovascular accident 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cognitive disorder 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Convulsion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Depressed level of consciousness 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dizziness 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Headache 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lethargy 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Leukoencephalopathy 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Syncope 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal and urinary disorders
Nephrolithiasis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Renal failure 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal failure acute 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal impairment 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Reproductive system and breast disorders
Dyspareunia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Diffuse alveolar damage 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Dyspnoea 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Epistaxis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Haemoptysis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypoxia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Obstructive airways disorder 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pleural effusion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pulmonary haemorrhage 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pulmonary oedema 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Respiratory failure 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tachypnoea 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Surgical and medical procedures
Abortion induced 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Catheter removal 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Vascular disorders
Hypotension 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Other (Not Including Serious) Adverse Events
Arm1, Group X (20 mg) Arm1, Group X (30 mg) Arm1, Group X (40 mg) Arm1 GroupX 60 mg Arm1 GroupX 80 mg Arm1 GroupY 20 mg Arm1 GroupY 30 mg Arm1 GroupY 40 mg Arm1 GroupY 60 mg Arm2 GroupX 30 mg Arm2 GroupX 45 mg Arm2 GroupX 60 mg Arm2 GroupX 80 mg Arm2 GroupY 30 mg Arm2 GroupY 45 mg Arm2 GroupY 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 8/8 (100%) 8/8 (100%) 10/10 (100%) 49/49 (100%) 11/11 (100%) 1/1 (100%) 4/4 (100%) 24/24 (100%) 5/5 (100%) 6/6 (100%) 9/9 (100%) 9/9 (100%) 9/9 (100%) 1/1 (100%) 7/7 (100%) 15/15 (100%)
Blood and lymphatic system disorders
Anaemia 3/8 (37.5%) 3/8 (37.5%) 1/10 (10%) 22/49 (44.9%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 9/24 (37.5%) 1/5 (20%) 0/6 (0%) 3/9 (33.3%) 4/9 (44.4%) 2/9 (22.2%) 0/1 (0%) 2/7 (28.6%) 7/15 (46.7%)
Bone marrow failure 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Coagulopathy 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Febrile neutropenia 4/8 (50%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypoprothrombinaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Leukocytosis 1/8 (12.5%) 1/8 (12.5%) 0/10 (0%) 6/49 (12.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Leukopenia 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Lymphadenopathy 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Neutropenia 0/8 (0%) 2/8 (25%) 2/10 (20%) 18/49 (36.7%) 2/11 (18.2%) 1/1 (100%) 2/4 (50%) 8/24 (33.3%) 2/5 (40%) 0/6 (0%) 2/9 (22.2%) 4/9 (44.4%) 6/9 (66.7%) 0/1 (0%) 2/7 (28.6%) 6/15 (40%)
Pancytopenia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Splenic infarction 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Splenomegaly 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Spontaneous haematoma 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Thrombocytopenia 2/8 (25%) 3/8 (37.5%) 4/10 (40%) 26/49 (53.1%) 3/11 (27.3%) 1/1 (100%) 4/4 (100%) 22/24 (91.7%) 5/5 (100%) 1/6 (16.7%) 3/9 (33.3%) 3/9 (33.3%) 6/9 (66.7%) 1/1 (100%) 4/7 (57.1%) 11/15 (73.3%)
Cardiac disorders
Aortic valve incompetence 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Atrial fibrillation 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Atrial flutter 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Atrioventricular block 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Atrioventricular block second degree 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bradycardia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cardiac disorder 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cardiac failure 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Cardiovascular disorder 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Coronary artery disease 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dilatation ventricular 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Left ventricular dysfunction 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Palpitations 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sinus bradycardia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Sinus tachycardia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Supraventricular extrasystoles 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Supraventricular tachycardia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tachyarrhythmia 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tachycardia 0/8 (0%) 2/8 (25%) 1/10 (10%) 6/49 (12.2%) 3/11 (27.3%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Ventricular arrhythmia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Ventricular extrasystoles 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Congenital, familial and genetic disorders
Antithrombin III deficiency 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Ear and labyrinth disorders
Deafness 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Deafness bilateral 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hearing impaired 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperacusis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vertigo 0/8 (0%) 1/8 (12.5%) 2/10 (20%) 5/49 (10.2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Endocrine disorders
Cushingoid 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Goitre 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperparathyroidism secondary 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hyperthyroidism 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypothyroidism 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Thyroid disorder 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Eye disorders
Conjunctivitis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Diplopia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Eye irritation 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyphaema 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Keratoconjunctivitis sicca 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Lacrimation increased 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Ocular hyperaemia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Ocular icterus 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pupillary disorder 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Visual Impairment 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Visual disturbance 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gastrointestinal disorders
Abdominal discomfort 0/8 (0%) 1/8 (12.5%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Abdominal distension 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Abdominal pain 2/8 (25%) 2/8 (25%) 3/10 (30%) 16/49 (32.7%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 7/24 (29.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 3/9 (33.3%) 0/1 (0%) 0/7 (0%) 3/15 (20%)
Abdominal pain lower 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Abdominal pain upper 0/8 (0%) 0/8 (0%) 2/10 (20%) 5/49 (10.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Anal discomfort 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Anal haemorrhage 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Ascites 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 2/9 (22.2%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Caecitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Constipation 2/8 (25%) 0/8 (0%) 1/10 (10%) 13/49 (26.5%) 3/11 (27.3%) 0/1 (0%) 1/4 (25%) 7/24 (29.2%) 0/5 (0%) 2/6 (33.3%) 2/9 (22.2%) 4/9 (44.4%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 5/15 (33.3%)
Diarrhoea 5/8 (62.5%) 5/8 (62.5%) 5/10 (50%) 41/49 (83.7%) 10/11 (90.9%) 0/1 (0%) 3/4 (75%) 15/24 (62.5%) 1/5 (20%) 3/6 (50%) 4/9 (44.4%) 6/9 (66.7%) 5/9 (55.6%) 1/1 (100%) 5/7 (71.4%) 10/15 (66.7%)
Dry mouth 0/8 (0%) 1/8 (12.5%) 2/10 (20%) 6/49 (12.2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 6/24 (25%) 0/5 (0%) 0/6 (0%) 2/9 (22.2%) 1/9 (11.1%) 2/9 (22.2%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Dyspepsia 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 2/9 (22.2%) 2/9 (22.2%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Dysphagia 2/8 (25%) 1/8 (12.5%) 0/10 (0%) 7/49 (14.3%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 2/7 (28.6%) 1/15 (6.7%)
Epigastric discomfort 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Eructation 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Faecal incontinence 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Flatulence 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gastric ulcer 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gastritis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Gastritis atrophic 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Gastrooesophageal reflux disease 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gingival bleeding 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 2/9 (22.2%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gingival disorder 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gingivitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Glossodynia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Haematemesis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Haematochezia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Haemorrhoids 1/8 (12.5%) 1/8 (12.5%) 0/10 (0%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Impaired gastric emptying 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lip haemorrhage 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Melaena 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Mouth haemorrhage 2/8 (25%) 2/8 (25%) 2/10 (20%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Mouth ulceration 2/8 (25%) 0/8 (0%) 0/10 (0%) 5/49 (10.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 3/6 (50%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Nausea 5/8 (62.5%) 5/8 (62.5%) 9/10 (90%) 31/49 (63.3%) 8/11 (72.7%) 0/1 (0%) 1/4 (25%) 16/24 (66.7%) 3/5 (60%) 4/6 (66.7%) 3/9 (33.3%) 7/9 (77.8%) 7/9 (77.8%) 1/1 (100%) 6/7 (85.7%) 12/15 (80%)
Odynophagia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Oesophageal pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oral discomfort 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oral disorder 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oral mucosal petechiae 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oral pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 6/49 (12.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Pancreatic calcification 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Proctalgia 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Rectal haemorrhage 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Reflux oesophagitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Saliva altered 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Stomatitis 2/8 (25%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 2/9 (22.2%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Stomatitis haemorrhagic 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tongue coated 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tongue discolouration 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Toothache 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Varices oesophageal 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vomiting 4/8 (50%) 2/8 (25%) 8/10 (80%) 23/49 (46.9%) 6/11 (54.5%) 0/1 (0%) 0/4 (0%) 9/24 (37.5%) 1/5 (20%) 2/6 (33.3%) 1/9 (11.1%) 5/9 (55.6%) 4/9 (44.4%) 1/1 (100%) 5/7 (71.4%) 7/15 (46.7%)
General disorders
Catheter related complication 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Catheter site haemorrhage 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Catheter site oedema 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Catheter site pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Catheter site related reaction 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Chest pain 0/8 (0%) 0/8 (0%) 1/10 (10%) 5/49 (10.2%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Chills 0/8 (0%) 1/8 (12.5%) 4/10 (40%) 15/49 (30.6%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 3/15 (20%)
Chronic fatigue syndrome 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cyst 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Face oedema 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fatigue 3/8 (37.5%) 5/8 (62.5%) 7/10 (70%) 36/49 (73.5%) 8/11 (72.7%) 1/1 (100%) 1/4 (25%) 19/24 (79.2%) 3/5 (60%) 3/6 (50%) 6/9 (66.7%) 4/9 (44.4%) 5/9 (55.6%) 0/1 (0%) 6/7 (85.7%) 12/15 (80%)
Feeling cold 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Gait disturbance 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
General physical health deterioration 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hyperthermia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypothermia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Inflammation 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Influenza like illness 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Local swelling 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Malaise 0/8 (0%) 0/8 (0%) 2/10 (20%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Mass 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Mucosal haemorrhage 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Mucosal inflammation 3/8 (37.5%) 3/8 (37.5%) 2/10 (20%) 2/49 (4.1%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Non-cardiac chest pain 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/1 (100%) 1/7 (14.3%) 0/15 (0%)
Oedema mucosal 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oedema peripheral 3/8 (37.5%) 2/8 (25%) 4/10 (40%) 16/49 (32.7%) 4/11 (36.4%) 0/1 (0%) 2/4 (50%) 6/24 (25%) 1/5 (20%) 1/6 (16.7%) 2/9 (22.2%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 3/7 (42.9%) 3/15 (20%)
Pain 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Pitting oedema 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pyrexia 1/8 (12.5%) 4/8 (50%) 2/10 (20%) 16/49 (32.7%) 3/11 (27.3%) 0/1 (0%) 1/4 (25%) 5/24 (20.8%) 2/5 (40%) 2/6 (33.3%) 4/9 (44.4%) 4/9 (44.4%) 2/9 (22.2%) 0/1 (0%) 3/7 (42.9%) 4/15 (26.7%)
Sensation of blood flow 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Thirst decreased 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hepatobiliary disorders
Cholelithiasis 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hepatic cyst 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hepatic failure 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hepatic function abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hepatomegaly 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperbilirubinaemia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 4/49 (8.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 1/5 (20%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Immune system disorders
Immunodeficiency 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Seasonal allergy 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Infections and infestations
Anal abscess 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Anal candidiasis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Aspergillosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bacterial infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 4/49 (8.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bronchitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Candida pneumonia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Candidiasis 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Catheter related infection 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Catheter sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Cellulitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Clostridium difficile colitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Condyloma acuminatum 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Conjunctivitis bacterial 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Enterobacter bacteraemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Enterobacter infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Enterococcal bacteraemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Enterococcal infection 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Enterococcal sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Escherichia infection 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Folliculitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Gastroenteritis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Herpes simplex 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Herpes virus infection 0/8 (0%) 1/8 (12.5%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Infection 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Klebsiella bacteraemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Klebsiella sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lower respiratory tract infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 2/4 (50%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Micrococcal sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Nasopharyngitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Oesophageal candidiasis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Oral candidiasis 2/8 (25%) 0/8 (0%) 1/10 (10%) 4/49 (8.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 2/9 (22.2%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Osteomyelitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Otitis externa 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Paronychia 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pharyngitis 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pilonidal cyst 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pneumonia 1/8 (12.5%) 1/8 (12.5%) 0/10 (0%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Pneumonia fungal 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pseudomonal bacteraemia 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pseudomonal sepsis 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pseudomonas infection 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Rash pustular 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Respiratory tract infection 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 1/1 (100%) 2/4 (50%) 5/24 (20.8%) 1/5 (20%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 3/15 (20%)
Rhinitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 1/1 (100%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sinusitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Staphylococcal infection 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Staphylococcal sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Streptococcal sepsis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tracheitis 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Urinary tract infection 2/8 (25%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 2/9 (22.2%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Viral infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vulvovaginal mycotic infection 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Injury, poisoning and procedural complications
Arthropod bite 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Contusion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Excoriation 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fall 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Haemothorax 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Open wound 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Post procedural oedema 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Procedural pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Scratch 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin injury 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin laceration 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tooth fracture 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Transfusion reaction 2/8 (25%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Investigations
Activated partial thromboplastin time shortened 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Alanine aminotransferase increased 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Anaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Anti-erythrocyte antibody positive 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Antithrombin III decreased 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Aspartate aminotransferase increased 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Aspiration biopsy 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Biopsy skin 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Blood albumin decreased 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood alkaline phosphatase increased 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Blood bicarbonate decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood bilirubin increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood calcium decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood creatine phosphokinase increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Blood creatinine increased 0/8 (0%) 1/8 (12.5%) 1/10 (10%) 10/49 (20.4%) 4/11 (36.4%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 4/15 (26.7%)
Blood fibrinogen increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood glucose increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Blood lactate dehydrogenase increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood magnesium decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood sodium increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood thyroid stimulating hormone increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 3/15 (20%)
Blood triglycerides increased 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood urea increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Blood uric acid increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Breath sounds abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
C-reactive protein increased 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 7/49 (14.3%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 4/15 (26.7%)
Clostridium difficile toxin test positive 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Computerised tomogram abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Ejection fraction decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrocardiogram QRS complex prolonged 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrocardiogram QT corrected interval prolonged 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrocardiogram QT prolonged 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 4/11 (36.4%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrocardiogram ST segment abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Electrocardiogram ST segment depression 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Electrocardiogram ST-T change 0/8 (0%) 1/8 (12.5%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Electrocardiogram T wave abnormal 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrocardiogram repolarisation abnormality 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fibrin D dimer increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fungus stool identified 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gamma-glutamyltransferase increased 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Glomerular filtration rate decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypophosphataemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
International normalised ratio increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Liver function test abnormal 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oxygen saturation decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Oxygen saturation increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Prostatic specific antigen increased 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Prothrombin time prolonged 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Prothrombin time shortened 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Red blood cells urine positive 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Transaminases increased 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Troponin increased 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Urine output decreased 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Weight decreased 3/8 (37.5%) 3/8 (37.5%) 3/10 (30%) 17/49 (34.7%) 4/11 (36.4%) 0/1 (0%) 0/4 (0%) 11/24 (45.8%) 0/5 (0%) 2/6 (33.3%) 2/9 (22.2%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 3/7 (42.9%) 3/15 (20%)
Weight increased 0/8 (0%) 0/8 (0%) 2/10 (20%) 4/49 (8.2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Metabolism and nutrition disorders
Anorexia 5/8 (62.5%) 4/8 (50%) 6/10 (60%) 32/49 (65.3%) 6/11 (54.5%) 0/1 (0%) 1/4 (25%) 10/24 (41.7%) 1/5 (20%) 2/6 (33.3%) 1/9 (11.1%) 3/9 (33.3%) 3/9 (33.3%) 0/1 (0%) 4/7 (57.1%) 8/15 (53.3%)
Dehydration 0/8 (0%) 0/8 (0%) 1/10 (10%) 9/49 (18.4%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 3/9 (33.3%) 2/9 (22.2%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Electrolyte imbalance 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Fluid overload 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Folate deficiency 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Gout 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypercalcaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Hyperglycaemia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 4/49 (8.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Hyperkalaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 5/49 (10.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 2/9 (22.2%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 4/15 (26.7%)
Hypermagnesaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Hyperphosphataemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperuricaemia 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Hypoalbuminaemia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hypocalcaemia 4/8 (50%) 1/8 (12.5%) 2/10 (20%) 17/49 (34.7%) 6/11 (54.5%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 1/9 (11.1%) 4/9 (44.4%) 0/1 (0%) 1/7 (14.3%) 4/15 (26.7%)
Hypoglycaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Hypokalaemia 4/8 (50%) 5/8 (62.5%) 1/10 (10%) 21/49 (42.9%) 7/11 (63.6%) 0/1 (0%) 1/4 (25%) 8/24 (33.3%) 3/5 (60%) 2/6 (33.3%) 1/9 (11.1%) 2/9 (22.2%) 3/9 (33.3%) 0/1 (0%) 2/7 (28.6%) 4/15 (26.7%)
Hypomagnesaemia 1/8 (12.5%) 1/8 (12.5%) 1/10 (10%) 6/49 (12.2%) 1/11 (9.1%) 0/1 (0%) 1/4 (25%) 2/24 (8.3%) 2/5 (40%) 2/6 (33.3%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyponatraemia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 7/49 (14.3%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 2/9 (22.2%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hypophagia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypophosphataemia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 9/49 (18.4%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 2/5 (40%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 3/9 (33.3%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Iron overload 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Malnutrition 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Metabolic alkalosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Podagra 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vitamin B6 deficiency 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vitamin D deficiency 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/8 (0%) 1/8 (12.5%) 2/10 (20%) 2/49 (4.1%) 3/11 (27.3%) 1/1 (100%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 2/9 (22.2%) 0/9 (0%) 1/1 (100%) 0/7 (0%) 4/15 (26.7%)
Arthritis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 2/9 (22.2%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Back pain 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 9/49 (18.4%) 3/11 (27.3%) 1/1 (100%) 0/4 (0%) 5/24 (20.8%) 0/5 (0%) 1/6 (16.7%) 3/9 (33.3%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 2/15 (13.3%)
Bone disorder 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bone pain 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Joint effusion 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Joint swelling 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Muscle spasms 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 5/15 (33.3%)
Muscular weakness 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Musculoskeletal chest pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 2/4 (50%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/1 (100%) 0/7 (0%) 0/15 (0%)
Musculoskeletal discomfort 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Musculoskeletal pain 0/8 (0%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Myalgia 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Neck pain 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Osteoarthritis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Osteonecrosis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pain in extremity 0/8 (0%) 0/8 (0%) 1/10 (10%) 4/49 (8.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 2/9 (22.2%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Pain in jaw 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pathological fracture 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Periostitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Polyarthritis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Shoulder pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/1 (100%) 0/7 (0%) 0/15 (0%)
Spinal osteoarthritis 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Synovial cyst 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Seborrhoeic keratosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tumour lysis syndrome 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Nervous system disorders
Ageusia 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 2/9 (22.2%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Aphasia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Balance disorder 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Carpal tunnel syndrome 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Coma 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Convulsion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Coordination abnormal 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Depressed level of consciousness 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dizziness 2/8 (25%) 0/8 (0%) 3/10 (30%) 7/49 (14.3%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 1/5 (20%) 2/6 (33.3%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dysarthria 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dysgeusia 0/8 (0%) 4/8 (50%) 2/10 (20%) 18/49 (36.7%) 5/11 (45.5%) 0/1 (0%) 1/4 (25%) 5/24 (20.8%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 1/9 (11.1%) 2/9 (22.2%) 0/1 (0%) 2/7 (28.6%) 5/15 (33.3%)
Facial palsy 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Headache 1/8 (12.5%) 1/8 (12.5%) 3/10 (30%) 10/49 (20.4%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 4/24 (16.7%) 1/5 (20%) 1/6 (16.7%) 2/9 (22.2%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 6/15 (40%)
Hemiplegia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypoaesthesia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypokinesia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lethargy 2/8 (25%) 0/8 (0%) 0/10 (0%) 4/49 (8.2%) 2/11 (18.2%) 0/1 (0%) 1/4 (25%) 3/24 (12.5%) 1/5 (20%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 2/15 (13.3%)
Meningeal disorder 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Monoparesis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Paraesthesia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Parkinson's disease 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Peripheral paralysis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Peripheral sensory neuropathy 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Polyneuropathy 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sensory disturbance 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Sensory loss 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Somnolence 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Speech disorder 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Syncope 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Tremor 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Psychiatric disorders
Agitation 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Anxiety 0/8 (0%) 0/8 (0%) 1/10 (10%) 5/49 (10.2%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 2/9 (22.2%) 0/1 (0%) 1/7 (14.3%) 2/15 (13.3%)
Confusional state 0/8 (0%) 0/8 (0%) 1/10 (10%) 4/49 (8.2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 2/9 (22.2%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Depressed mood 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Depression 0/8 (0%) 1/8 (12.5%) 2/10 (20%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Disorientation 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hallucination 0/8 (0%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Insomnia 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 11/49 (22.4%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 1/5 (20%) 1/6 (16.7%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 2/7 (28.6%) 1/15 (6.7%)
Mood altered 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Nightmare 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Restlessness 0/8 (0%) 0/8 (0%) 2/10 (20%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Sleep disorder 1/8 (12.5%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal and urinary disorders
Anuria 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Bladder spasm 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Calculus ureteric 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Dysuria 2/8 (25%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Haematuria 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Incontinence 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Ketonuria 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Nocturia 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pollakiuria 0/8 (0%) 2/8 (25%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Polyuria 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Proteinuria 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal failure 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal failure acute 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 1/6 (16.7%) 0/9 (0%) 2/9 (22.2%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Renal impairment 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 4/49 (8.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Urethral pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Urinary incontinence 0/8 (0%) 0/8 (0%) 0/10 (0%) 4/49 (8.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Urinary retention 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Breast swelling 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Metrorrhagia 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pelvic pain 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Penile pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Prostatitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Cough 2/8 (25%) 2/8 (25%) 5/10 (50%) 12/49 (24.5%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 7/24 (29.2%) 2/5 (40%) 0/6 (0%) 2/9 (22.2%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 2/7 (28.6%) 5/15 (33.3%)
Dysphonia 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dyspnoea 4/8 (50%) 3/8 (37.5%) 4/10 (40%) 11/49 (22.4%) 6/11 (54.5%) 0/1 (0%) 0/4 (0%) 4/24 (16.7%) 1/5 (20%) 1/6 (16.7%) 4/9 (44.4%) 0/9 (0%) 3/9 (33.3%) 0/1 (0%) 2/7 (28.6%) 4/15 (26.7%)
Dyspnoea exacerbated 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dyspnoea exertional 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Emphysema 1/8 (12.5%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Epistaxis 3/8 (37.5%) 0/8 (0%) 1/10 (10%) 12/49 (24.5%) 1/11 (9.1%) 0/1 (0%) 1/4 (25%) 6/24 (25%) 1/5 (20%) 2/6 (33.3%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 1/1 (100%) 0/7 (0%) 3/15 (20%)
Haemoptysis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hiccups 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hyperventilation 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypocapnia 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hypoxia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 1/15 (6.7%)
Lung consolidation 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Lung infiltration 0/8 (0%) 0/8 (0%) 1/10 (10%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Nasal dryness 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Painful respiration 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pharyngeal haemorrhage 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pharyngolaryngeal pain 1/8 (12.5%) 1/8 (12.5%) 2/10 (20%) 4/49 (8.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 3/24 (12.5%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Pleural effusion 1/8 (12.5%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 3/11 (27.3%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pleuritic pain 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pneumonitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pneumothorax 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Productive cough 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Pulmonary congestion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pulmonary fibrosis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pulmonary oedema 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Rales 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Respiratory acidosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 0/15 (0%)
Respiratory alkalosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Respiratory distress 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 1/4 (25%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Respiratory gas exchange disorder 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Rhinorrhoea 0/8 (0%) 0/8 (0%) 1/10 (10%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Rhonchi 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Sinus congestion 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Tachypnoea 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Wheezing 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin and subcutaneous tissue disorders
Alopecia 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 2/11 (18.2%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Blood blister 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Decubitus ulcer 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dermatitis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dermatitis acneiform 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Dry skin 0/8 (0%) 0/8 (0%) 0/10 (0%) 3/49 (6.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Ecchymosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Eczema 0/8 (0%) 0/8 (0%) 0/10 (0%) 2/49 (4.1%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Erythema 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hyperhidrosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 4/49 (8.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Ingrowing nail 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Night sweats 0/8 (0%) 0/8 (0%) 1/10 (10%) 4/49 (8.2%) 1/11 (9.1%) 0/1 (0%) 1/4 (25%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 3/15 (20%)
Petechiae 4/8 (50%) 0/8 (0%) 1/10 (10%) 8/49 (16.3%) 4/11 (36.4%) 0/1 (0%) 0/4 (0%) 2/24 (8.3%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Pruritus 0/8 (0%) 0/8 (0%) 1/10 (10%) 3/49 (6.1%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/1 (0%) 1/7 (14.3%) 2/15 (13.3%)
Rash 2/8 (25%) 1/8 (12.5%) 2/10 (20%) 6/49 (12.2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 2/9 (22.2%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 2/15 (13.3%)
Rash erythematous 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Rash generalised 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Rash pruritic 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Scab 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin discolouration 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin disorder 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Skin exfoliation 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin fissures 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin lesion 0/8 (0%) 2/8 (25%) 1/10 (10%) 2/49 (4.1%) 0/11 (0%) 1/1 (100%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 1/6 (16.7%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Skin ulcer 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Subcutaneous emphysema 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 1/5 (20%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Vascular disorders
Deep vein thrombosis 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Flushing 0/8 (0%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Haematoma 1/8 (12.5%) 0/8 (0%) 2/10 (20%) 6/49 (12.2%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Hypertension 1/8 (12.5%) 1/8 (12.5%) 2/10 (20%) 2/49 (4.1%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Hypotension 2/8 (25%) 2/8 (25%) 1/10 (10%) 8/49 (16.3%) 2/11 (18.2%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 1/6 (16.7%) 1/9 (11.1%) 1/9 (11.1%) 0/9 (0%) 0/1 (0%) 1/7 (14.3%) 3/15 (20%)
Lymphoedema 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Orthostatic hypertension 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 1/11 (9.1%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Orthostatic hypotension 0/8 (0%) 0/8 (0%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 1/15 (6.7%)
Phlebitis 1/8 (12.5%) 0/8 (0%) 0/10 (0%) 1/49 (2%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 1/9 (11.1%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Thrombophlebitis 0/8 (0%) 0/8 (0%) 1/10 (10%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 1/24 (4.2%) 0/5 (0%) 0/6 (0%) 1/9 (11.1%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)
Venoocclusive disease 0/8 (0%) 1/8 (12.5%) 0/10 (0%) 0/49 (0%) 0/11 (0%) 0/1 (0%) 0/4 (0%) 0/24 (0%) 0/5 (0%) 0/6 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/1 (0%) 0/7 (0%) 0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the polled data (ie, data from all sites) in the clinical trial.

Results Point of Contact

Name/Title Study Director
Organization Novartis Pharmaceuticals
Phone 862-778-8300
Email
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00621244
Other Study ID Numbers:
  • CLBH589B2102
  • 2005-003670-26
First Posted:
Feb 22, 2008
Last Update Posted:
Jan 5, 2021
Last Verified:
Jul 1, 2017