Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
Sponsor
AiCuris Anti-infective Cures AG (Industry)
Overall Status
Completed
CT.gov ID
NCT01063829
Collaborator
Quintiles, Inc. (Industry)
133
24
4
21
5.5
0.3
Study Details
Study Description
Brief Summary
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
133 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose regimen 1 60 mg AIC246, one tablet per day |
Drug: 60 mg AIC246
Oral administration
|
| Experimental: Dose regimen 2 120 mg AIC246, one tablet per day |
Drug: 120 mg AIC246
Oral administration
|
| Experimental: Dose regimen 3 240 mg AIC246, one tablet per day |
Drug: 240 mg AIC246
Oral administration
|
| Other: Placebo Placebo arm |
Other: Placebo
Oral administration
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With "HCMV Prophylaxis Failure" [84 days]
- Time to Onset of "HCMV Prophylaxis Failure" [84 days]
Secondary Outcome Measures
- Number of Patients With Systemic Detectable HCMV Replication. [84 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Seropositive for HCMV IgG antibodies before transplantation
-
First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
-
Evidence of post transplantation engraftment
-
Able to swallow tablets.
Exclusion Criteria:
-
Previous anti-HCMV therapy after this allogeneic HBPC transplantation
-
Mismatched or cord blood transplant recipients
-
Current or history of end-organ HCMV disease
-
Graft versus host disease (GVHD)
-
Impaired liver function
-
Reduced renal function
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Medical Center | Los Angeles | California | United States | |
| 2 | Stanford University Hospital | Stanford | California | United States | |
| 3 | Denver St. Lukes Presbyterian | Denver | Colorado | United States | |
| 4 | University of Florida | Gainesville | Florida | United States | |
| 5 | University of Chicago Medical Center | Chicago | Illinois | United States | |
| 6 | Loyola University Chicago | Maywood | Illinois | United States | |
| 7 | Indiana BMT | Beech Grove | Indiana | United States | |
| 8 | University Of Iowa | Iowa City | Iowa | United States | |
| 9 | Dana Farber Cancer Institute, | Boston | Massachusetts | United States | |
| 10 | Karmanos Cancer Institute | Detroit | Michigan | United States | |
| 11 | University of Minnesota | Minneapolis | Minnesota | United States | |
| 12 | Jeanes Hospital of TUHS | Philadelphia | Pennsylvania | United States | |
| 13 | UPMC Cancer Center | Pittsburgh | Pennsylvania | United States | |
| 14 | MD Anderson Cancer Center | Houston | Texas | United States | |
| 15 | Universitaetsklinikum Dresden | Dresden | Germany | ||
| 16 | Universitaetsklinikum Erlangen-PS | Erlangen, | Germany | ||
| 17 | Universitätsklinikum Freiburg | Freiburg | Germany | ||
| 18 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | ||
| 19 | Universitaeetsklinikum Heidelberg, , | Heidelberg | Germany | ||
| 20 | Universitaetsklinikum Mainz | Mainz | Germany | ||
| 21 | Universitaetsklinikum Muenster | Muenster | Germany | ||
| 22 | Klinikum Nuernberg Nord | Nuernberg | Germany | ||
| 23 | Robert-Bosch-Krankenhaus | Stuttgart | Germany | ||
| 24 | Universitaetsklinikum Wuerzburg | Würzburg | Germany |
Sponsors and Collaborators
- AiCuris Anti-infective Cures AG
- Quintiles, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AiCuris Anti-infective Cures AG
ClinicalTrials.gov Identifier:
NCT01063829
Other Study ID Numbers:
- AIC246-01-II-02
First Posted:
Feb 5, 2010
Last Update Posted:
Feb 13, 2018
Last Verified:
Dec 1, 2010
Keywords provided by AiCuris Anti-infective Cures AG
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 133 patients were randomized to the trial; 2 randomized patients did not receive the assigned study drug ( 1 Patient died and 1 Patient had CMV reactivation before intended administartion of first dose) |
| Arm/Group Title | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AIC246: Oral Administration | AIC246: Oral Administration | AIC246: Oral Administration | Placebo: Oral Administration |
| Period Title: Overall Study | ||||
| STARTED | 33 | 31 | 34 | 33 |
| COMPLETED | 17 | 21 | 24 | 12 |
| NOT COMPLETED | 16 | 10 | 10 | 21 |
Baseline Characteristics
| Arm/Group Title | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | AIC246: Oral Administration | AIC246: Oral Administration | AIC246: Oral Administration | Placebo: Oral Administration | Total of all reporting groups |
| Overall Participants | 33 | 31 | 34 | 33 | 131 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
50.5
(13.03)
|
51.6
(12.79)
|
50.7
(11.78)
|
51.8
(13.41)
|
51.1
(12.62)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
19
57.6%
|
9
29%
|
12
35.3%
|
14
42.4%
|
54
41.2%
|
| Male |
14
42.4%
|
22
71%
|
22
64.7%
|
19
57.6%
|
77
58.8%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
18
54.5%
|
19
61.3%
|
17
50%
|
15
45.5%
|
69
52.7%
|
| Germany |
15
45.5%
|
12
38.7%
|
17
50%
|
18
54.5%
|
62
47.3%
|
Outcome Measures
| Title | Number of Participants With "HCMV Prophylaxis Failure" |
|---|---|
| Description | |
| Time Frame | 84 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AIC246: Oral Administration | AIC246: Oral Administration | AIC246: Oral Administration | Placebo: Oral Administration |
| Measure Participants | 33 | 31 | 34 | 33 |
| Count of Participants [Participants] |
16
48.5%
|
10
32.3%
|
10
29.4%
|
21
63.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (240 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (120 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (60 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.321 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Time to Onset of "HCMV Prophylaxis Failure" |
|---|---|
| Description | |
| Time Frame | 84 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AIC246: Oral Administration | AIC246: Oral Administration | AIC246: Oral Administration | Placebo: Oral Administration |
| Measure Participants | 33 | 31 | 34 | 33 |
| Number [days] |
7
|
6
|
2
|
12
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (240 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (120 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.126 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (60 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.148 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Number of Patients With Systemic Detectable HCMV Replication. |
|---|---|
| Description | |
| Time Frame | 84 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AIC246: Oral Administration | AIC246: Oral Administration | AIC246: Oral Administration | Placebo: Oral Administration |
| Measure Participants | 33 | 31 | 34 | 33 |
| Count of Participants [Participants] |
7
21.2%
|
5
16.1%
|
2
5.9%
|
12
36.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (240 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (120 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | AIC246 (60 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.321 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo | ||||
| Arm/Group Description | AIC246: Oral Administration | AIC246: Oral Administration | AIC246: Oral Administration | Placebo: Oral Administration | ||||
All Cause Mortality |
||||||||
| AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/33 (6.1%) | 1/31 (3.2%) | 1/34 (2.9%) | 1/33 (3%) | ||||
Serious Adverse Events |
||||||||
| AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/33 (39.4%) | 15/31 (48.4%) | 12/34 (35.3%) | 16/33 (48.5%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Thrombocytopenia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Febrile Neutropenia | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 2/33 (6.1%) | 2 |
| Anaemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Cardiac disorders | ||||||||
| Anginga Pectoris | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Atrial Fibrillation | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pericarditis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Gastritis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Vomitting | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Nausea | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| General disorders | ||||||||
| General Physical Health Deterioration | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Generalised Oedema | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pyrexia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 3/33 (9.1%) | 3 |
| Hepatobiliary disorders | ||||||||
| Venoocclusive Liver Disease | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Immune system disorders | ||||||||
| Acute Graft Versus Host Disease in Intestine | 4/33 (12.1%) | 4 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 2/33 (6.1%) | 2 |
| Acute Graft Versus Host Disease in Liver | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Graft Versus Host Disease | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Acute Graft Versus Host Disease in Skin | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Infections and infestations | ||||||||
| Pneumonia | 2/33 (6.1%) | 2 | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Epstein-Barr Virus Infestcion | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Cytomegalovirus Infection | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 2/33 (6.1%) | 2 |
| Alcaligenes Infection | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Bacteraemia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Clostridial Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Enterococcal Bacteraemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Human Herpesvirus 6 Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Oral Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Pneumonia Primary Atypical | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Pneumonia Respiratory Syncytial Viral | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Sepsis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Septic Shock | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Device Related Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 2 |
| Enterobacter Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Herpes Virus Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Pneumonia Bacterial | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Upper Respiratory Tract Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Spinal Compression Fracture | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Transplant Failure | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Investigations | ||||||||
| Hepatic Enzyme Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Liver Function Test | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Staphylococcus Test Positive | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Diabetic Ketoacidosis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hyperkalaemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypoglykaemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hyponatraemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back Pain | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Flank Pain | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Acute Myeloid Leukaemia | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Leukaemia Recurrent | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Lymphoma | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Acute Lymphocytic Leukaemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Diffuse Large B-Cell Lymphoma Recurrent | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Myelodysplastic Syndrome | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Acute Myeloid Leukaemia (in Remission) | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Non-Hodgkin's Lymphoma Recurrent | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Nervous system disorders | ||||||||
| Loss of Consciousness | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Paraesthesia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Syncope | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Convulsion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Renal and urinary disorders | ||||||||
| Renal Failure | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute Respiratory Failure | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pulmonary Embolism | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/33 (93.9%) | 29/31 (93.5%) | 34/34 (100%) | 33/33 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 3/33 (9.1%) | 5 | 2/31 (6.5%) | 2 | 4/34 (11.8%) | 4 | 2/33 (6.1%) | 2 |
| Neutropenia | 2/33 (6.1%) | 2 | 2/31 (6.5%) | 2 | 3/34 (8.8%) | 3 | 2/33 (6.1%) | 2 |
| Thrombocytopenia | 2/33 (6.1%) | 2 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Splenomegaly | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Eosinophilia | 1/33 (3%) | 2 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Monocytosis | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pancytopenia | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Febrile Neutropenia | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Coagulopathy | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lymphopenia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lymph Node Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Cardiac disorders | ||||||||
| Tachycardia | 2/33 (6.1%) | 2 | 3/31 (9.7%) | 3 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Angina Pectoris | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Pericardial Effusion | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pericarditis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Sinus Arrhythmia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Congenital, familial and genetic disorders | ||||||||
| Chimerism | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Auricular Swelling | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Middle Ear Effusion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Tinnitus | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Vertigo | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Dysacusis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Ear Congestion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Ear Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Hyperacusis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Hypoacusis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Inner Ear Inflammation | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Endocrine disorders | ||||||||
| Cushingoid | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Hyperparathyroidism | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypothyroidism | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Inappropriate Antidiuretic Hormone Secretion | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Thyroid Disorder | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Eye disorders | ||||||||
| Dry Eye | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 5/34 (14.7%) | 5 | 1/33 (3%) | 1 |
| Conjunctivitis | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Vision Blurred | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Cataract | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Eye Irritation | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lacrimation Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Conjuctival Hyperaemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Eylid Oedema | 1/33 (3%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Eye Discharge | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Eye Pruritus | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Ocular Discomfort | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Sicca Syndrome | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Visual Impairment | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lagophthalmos | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 9/33 (27.3%) | 11 | 9/31 (29%) | 11 | 11/34 (32.4%) | 14 | 10/33 (30.3%) | 13 |
| Nausea | 7/33 (21.2%) | 8 | 8/31 (25.8%) | 16 | 7/34 (20.6%) | 7 | 11/33 (33.3%) | 11 |
| Vomitting | 4/33 (12.1%) | 4 | 10/31 (32.3%) | 11 | 8/34 (23.5%) | 8 | 4/33 (12.1%) | 7 |
| Constipation | 4/33 (12.1%) | 5 | 3/31 (9.7%) | 3 | 3/34 (8.8%) | 3 | 1/33 (3%) | 1 |
| Abdominal Pain | 3/33 (9.1%) | 3 | 3/31 (9.7%) | 3 | 3/34 (8.8%) | 3 | 5/33 (15.2%) | 6 |
| Dyspepsia | 1/33 (3%) | 1 | 2/31 (6.5%) | 3 | 4/34 (11.8%) | 4 | 1/33 (3%) | 1 |
| Abdominal Pain Upper | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 4/34 (11.8%) | 4 | 2/33 (6.1%) | 2 |
| Abdominal Distension | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 3 | 0/33 (0%) | 0 |
| Abdominal Discomfort | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Dry Mouth | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 4/33 (12.1%) | 4 |
| Flatulence | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Proctalgia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 1/33 (3%) | 1 |
| Dysphagia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Gastrooesophageal Reflux Disease | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Stomatitis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Anorectal Discomfort | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Ascites | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Breath Odour | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Colitis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Colitis Ischaemic | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Gastritis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Gastrointestinal Haemorrhage | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Haemorrhoids | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Lip Dry | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Lip Swelling | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lip Ulceration | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Oral Discomfort | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Swollen Tongue | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Gingivitis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Oral Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| General disorders | ||||||||
| Fatigue | 3/33 (9.1%) | 6 | 8/31 (25.8%) | 9 | 4/34 (11.8%) | 6 | 5/33 (15.2%) | 5 |
| Oedema Peripheral | 4/33 (12.1%) | 4 | 3/31 (9.7%) | 3 | 8/34 (23.5%) | 8 | 3/33 (9.1%) | 3 |
| Pyrexia | 3/33 (9.1%) | 3 | 4/31 (12.9%) | 4 | 5/34 (14.7%) | 5 | 6/33 (18.2%) | 6 |
| Oedema | 1/33 (3%) | 1 | 3/31 (9.7%) | 3 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Chills | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Asthenia | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Catheter Site Erythema | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Catheter Site Pain | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Chest Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Face Oedema | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Local Swelling | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Malaise | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Non-Cardiac Chest Pain | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Application Site Hypersensitivity | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Axillary Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Gait Distrubance | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 1/33 (3%) | 2 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Cholestasis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hyperbilirubinaemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Venoocclusive Liver Disease | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Immune system disorders | ||||||||
| Acute Graft Versus Host Disease | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 2 |
| Acute Graft Versus Host Disease in Skin | 3/33 (9.1%) | 4 | 5/31 (16.1%) | 7 | 6/34 (17.6%) | 7 | 2/33 (6.1%) | 3 |
| Acute Graft Versus Host Disease in Intestine | 3/33 (9.1%) | 3 | 0/31 (0%) | 0 | 5/34 (14.7%) | 6 | 4/33 (12.1%) | 5 |
| Graft Versus Host Disease | 1/33 (3%) | 1 | 2/31 (6.5%) | 3 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Acute Graft Versus Host Disease in Liver | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 3/33 (9.1%) | 3 |
| Drug Hypersensitivity | 1/33 (3%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Chronic Graft Versus Host Disease | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Seasonal Allergy | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Infections and infestations | ||||||||
| Cytomegalovirus Infection | 6/33 (18.2%) | 6 | 6/31 (19.4%) | 6 | 5/34 (14.7%) | 5 | 11/33 (33.3%) | 11 |
| Candidiasis | 4/33 (12.1%) | 4 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 3/33 (9.1%) | 3 |
| Pneumonia | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 3/34 (8.8%) | 3 | 0/33 (0%) | 0 |
| Upper Respiratory Tract Infection | 2/33 (6.1%) | 2 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Nasopharyngitis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 4/34 (11.8%) | 4 | 0/33 (0%) | 0 |
| Urinary Tract Infection | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 2/33 (6.1%) | 2 |
| Eppstein-Barr Virus Infection | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Pseudomonas Infection | 2/33 (6.1%) | 2 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Sinusitis | 0/33 (0%) | 0 | 3/31 (9.7%) | 3 | 0/34 (0%) | 0 | 2/33 (6.1%) | 2 |
| Bacteraemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Folliculitis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Oral Infection | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Respiratory Tract Infection | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Staphylococcal Infection | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Urinary Tract Infection Enterococcal | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Eppstein-Barr Viraemia | 1/33 (3%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Rhinitis | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Alcaligenes Infection | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Bacterial Infection | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| BK Virus Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Body Tinea | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Bronchitis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Cellulitis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Clostridial Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Cystitis Viral | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Enterococcal Bacteraemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Herpes Simplex | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Human Herpesvirus 6 Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Klebsiella Bacteraemia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Micrococcus Infection | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Oesphageal Candidiasis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Oral Candidiasis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Oral Herpes | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Parainfluenzae Virus Infection | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pharyngitis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pneumonia Herpes Viral | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pneumonia Primary Atypical | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Pneumonia Respiratory Syncytial Viral | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Septic Shock | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Staphylococcal Bacteraemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Stenotrophomonas Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Adenovirus Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Cytomegalovirus Viraemia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Device Related Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 2 |
| Enterobacter Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Fungal Skin Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Herpes Virus Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Paronychia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Parotitis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Pneumonia Bacterial | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Skin Infection | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Skin Laceration | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Contusion | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Fall | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Limb Injury | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Procedural Pain | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Scratch | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Spinal Compression Fracture | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Sunburn | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Suture Related Complication | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Investigations | ||||||||
| Hepatic Enzyme Increased | 2/33 (6.1%) | 2 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Blood Creatinine Increased | 1/33 (3%) | 1 | 1/31 (3.2%) | 3 | 1/34 (2.9%) | 1 | 3/33 (9.1%) | 3 |
| Alanine Aminotransferase Increased | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 2/34 (5.9%) | 3 | 1/33 (3%) | 1 |
| Aspartate Aminotransferase Increased | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Blood Alkaline Phosphatase Increased | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Blood Folate Decreased | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 1/33 (3%) | 1 |
| Blood Urea Increased | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Red Blood Cell Morphology Abnormal | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Transaminases Increased | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Weight Decreased | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Blood Creatine Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Liver Function Test | 1/33 (3%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Antithrombin III Decreased | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Aspergillus Test Positive | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Blood Amylase Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Blood Fibrinogen Decreased | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Blood Potassium Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Blood Testosterone Decreased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| C-Reactive Protein Increased | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Computerised Tomogram Abnormal | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Cytomegalovirus Test Positive | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 2/33 (6.1%) | 2 |
| Electrocardiogram QT Prolonged | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Electrocardiogram ST Segment Elevation | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Epstein-Barr Virus Test Positive | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Gamma-Glutamyltransferase Increased | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Lipase Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Polyomavirus Test Positive | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Weight Increased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| White Blood Cell Count Decreased | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Staphylococcus Test Positive | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Decreased Appetite | 4/33 (12.1%) | 4 | 2/31 (6.5%) | 2 | 5/34 (14.7%) | 5 | 3/33 (9.1%) | 3 |
| Hyperkalaemia | 4/33 (12.1%) | 4 | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 1/33 (3%) | 1 |
| Dehydration | 3/33 (9.1%) | 3 | 3/31 (9.7%) | 3 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Hypokalaemia | 1/33 (3%) | 1 | 3/31 (9.7%) | 3 | 2/34 (5.9%) | 2 | 1/33 (3%) | 1 |
| Hyperglycaemia | 1/33 (3%) | 1 | 3/31 (9.7%) | 3 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Diabetes Mellitus | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 2/33 (6.1%) | 2 |
| Hypomagnesaemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Diabetic Ketoacidosis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Electrolyte Imbalance | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Fluid Overload | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Fluid Retention | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Food Intolerance | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Haemosiderosis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hyperphosphataemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypocalcaemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypoglycaemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hyponatraemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypoproteinaemia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hyperuricaemia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Vitamin D Deficiency | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back Pain | 2/33 (6.1%) | 2 | 4/31 (12.9%) | 4 | 2/34 (5.9%) | 3 | 1/33 (3%) | 1 |
| Muscles Spasms | 1/33 (3%) | 2 | 2/31 (6.5%) | 2 | 4/34 (11.8%) | 6 | 0/33 (0%) | 0 |
| Bone Pain | 2/33 (6.1%) | 2 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Myalgia | 1/33 (3%) | 1 | 2/31 (6.5%) | 2 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Arthralgia | 2/33 (6.1%) | 3 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Musculoskeletal Pain | 2/33 (6.1%) | 3 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Pain in Extremity | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Muscular Weakness | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Myopathy | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Arthrophathy | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Chest Wall Mass | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Exostosis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Muscle Atrophy | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Musculoskeletal Stiffness | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Osteonecrosis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Osteoporosis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Musculoskeletal Chest Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Myosclerosis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Acute Myeloid Leukaemia | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Leukaemia Recurrent | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Myelodysplastic Syndrome | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Acute Lymphocytic Leukaemia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Diffuse Large B-Cell Lymphoma Recurrent | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lymphoma | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Melanocytic Naevus | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Multiple Myeloma | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Acute Myeloid Leukaemia (in Remission) | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Epstein-Barr Virus Associated Lymphoproliferative Disorder | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Nervous system disorders | ||||||||
| Headache | 4/33 (12.1%) | 4 | 3/31 (9.7%) | 3 | 8/34 (23.5%) | 8 | 3/33 (9.1%) | 3 |
| Neuropathy Peripheral | 3/33 (9.1%) | 3 | 3/31 (9.7%) | 3 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Tremor | 1/33 (3%) | 1 | 3/31 (9.7%) | 3 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Dizziness | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Dysgeusia | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Paraesthesia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Polyneuropathy | 2/33 (6.1%) | 2 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Somnolence | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Burning Sensation | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Hypoaestesia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Loss of Consciousness | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Neuralgia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Nystagmus | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Restless Leg Syndrome | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Sinus Headache | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Syncope | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Ageusia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Balance Disorder | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Convulsion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| VIIth Nerve Paralysis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Psychiatric disorders | ||||||||
| Insomnia | 5/33 (15.2%) | 5 | 4/31 (12.9%) | 4 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Depression | 3/33 (9.1%) | 3 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Anxiety | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Psychotic Disorder | 0/33 (0%) | 0 | 1/31 (3.2%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Decreased Activitiy | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Delirium | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Mood Swings | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Panick Attack | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Stress | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Adjustment Disorders | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Fear | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 2 |
| Libido Decreased | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Restlessness | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Renal and urinary disorders | ||||||||
| Renal Failure | 5/33 (15.2%) | 5 | 5/31 (16.1%) | 5 | 3/34 (8.8%) | 3 | 2/33 (6.1%) | 2 |
| Nocturia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 3/34 (8.8%) | 3 | 0/33 (0%) | 0 |
| Dysuria | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 2/34 (5.9%) | 2 | 2/33 (6.1%) | 2 |
| Micturition Urgency | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Haematuria | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Inconinence | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pyuria | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Renal Failure Acute | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 2 |
| Bladder Spasm | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Reproductive system and breast disorders | ||||||||
| Vulvovaginal Dryness | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Vulvovaginal Pruritus | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Atropic Vulvovaginitis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Dyspareunia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Erectile Dysfunction | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Genital Lesion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Menorrhagia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Scrotal Erythema | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Vaginal Discharge | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Breast Pain | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Breast Swelling | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 2/33 (6.1%) | 2 | 8/31 (25.8%) | 11 | 5/34 (14.7%) | 5 | 1/33 (3%) | 1 |
| Oropharyngeal Pain | 2/33 (6.1%) | 3 | 3/31 (9.7%) | 3 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Dyspnoea | 2/33 (6.1%) | 2 | 1/31 (3.2%) | 1 | 3/34 (8.8%) | 3 | 2/33 (6.1%) | 2 |
| Rhinorrhoea | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 3/34 (8.8%) | 3 | 1/33 (3%) | 1 |
| Lung Infiltration | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Epistaxis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Nasal Congestion | 0/33 (0%) | 0 | 2/31 (6.5%) | 2 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Postnasal Drip | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Pulmonary Ebolism | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Throat Irritation | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Bronchial Obstruction | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Dysphonia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Dyspnoea Exertional | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Emphysema | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypoxia | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lung Disorder | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Painful Respiration | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Pharyngeal Erythema | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pleural Effusion | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pleurisy | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Productive Cough | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Respiratory Disorder | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Sinus Congestion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Choking | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Chronic Obstructive Pulmonary Disease | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Pulmonary Congestion | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Pulmonary Oedema | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Rhinitis Allergic | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Sleep Apnoea Syndrome | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Wheezing | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 4/33 (12.1%) | 5 | 5/31 (16.1%) | 7 | 4/34 (11.8%) | 6 | 6/33 (18.2%) | 7 |
| Puritus | 2/33 (6.1%) | 2 | 4/31 (12.9%) | 4 | 5/34 (14.7%) | 5 | 3/33 (9.1%) | 4 |
| Erythema | 0/33 (0%) | 0 | 4/31 (12.9%) | 5 | 4/34 (11.8%) | 8 | 2/33 (6.1%) | 2 |
| Dry Skin | 1/33 (3%) | 1 | 3/31 (9.7%) | 3 | 1/34 (2.9%) | 1 | 2/33 (6.1%) | 2 |
| Rash Erythematous | 1/33 (3%) | 2 | 0/31 (0%) | 0 | 1/34 (2.9%) | 2 | 0/33 (0%) | 0 |
| Petechiae | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 3 | 0/33 (0%) | 0 |
| Hyperhidrosis | 1/33 (3%) | 1 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Night Sweats | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 2/34 (5.9%) | 2 | 0/33 (0%) | 0 |
| Rash Pruritic | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Skin Hyperpigmentation | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Actinic Keratosis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Acute Febrile Neutrophilic Dermatosis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Alopecia | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Blood Blister | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Decubitus Ulcer | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Dermal Cyst | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Dermatitis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Dermatitis Contact | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Hypoaesthesia Facial | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Lichenfication | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Nail Disorder | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Palmar Eythema | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Perivascular Dermatitis | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Pruritis Generalised | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Rash Maculo-Papular | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Rash Morbilliform | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Rash Papular | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Skin Discolouration | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Skin Exfoliation | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Skin Ulcer | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Ecchymosis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Vascular disorders | ||||||||
| Hypotension | 2/33 (6.1%) | 2 | 2/31 (6.5%) | 2 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Hypertension | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 3/34 (8.8%) | 3 | 2/33 (6.1%) | 2 |
| Circulatory Collapse | 0/33 (0%) | 0 | 1/31 (3.2%) | 1 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Deep Vain Thrombosis | 1/33 (3%) | 1 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 0/33 (0%) | 0 |
| Flushing | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 1/33 (3%) | 1 |
| Hot Flush | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Orthostatic Hypotension | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 1/34 (2.9%) | 1 | 0/33 (0%) | 0 |
| Ischaemia | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
| Varicophlebitis | 0/33 (0%) | 0 | 0/31 (0%) | 0 | 0/34 (0%) | 0 | 1/33 (3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Every Publication, disclosure or other use of Information conveyed to the Institution and the Investigator in relation to the Trial and of data and results derived from the Performance of the Trial requires the express written consent of Sponsor.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | AiCuris Anti-infective Cures GmbH |
| Phone | 004920231763 ext 0 |
| info@aicuris.com |
Responsible Party:
AiCuris Anti-infective Cures AG
ClinicalTrials.gov Identifier:
NCT01063829
Other Study ID Numbers:
- AIC246-01-II-02
First Posted:
Feb 5, 2010
Last Update Posted:
Feb 13, 2018
Last Verified:
Dec 1, 2010