Trial Outcomes & Findings for Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients (NCT NCT01063829)
NCT ID: NCT01063829
Last Updated: 2018-02-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
84 days
Results posted on
2018-02-13
Participant Flow
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)
Participant milestones
| Measure |
AIC246 (60 mg)
AIC246: Oral Administration
|
AIC246 (120 mg)
AIC246: Oral Administration
|
AIC246 (240 mg)
AIC246: Oral Administration
|
Placebo
Placebo: Oral Administration
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
34
|
33
|
|
Overall Study
COMPLETED
|
17
|
21
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
10
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
Baseline characteristics by cohort
| Measure |
AIC246 (60 mg)
n=33 Participants
AIC246: Oral Administration
|
AIC246 (120 mg)
n=31 Participants
AIC246: Oral Administration
|
AIC246 (240 mg)
n=34 Participants
AIC246: Oral Administration
|
Placebo
n=33 Participants
Placebo: Oral Administration
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 13.03 • n=93 Participants
|
51.6 years
STANDARD_DEVIATION 12.79 • n=4 Participants
|
50.7 years
STANDARD_DEVIATION 11.78 • n=27 Participants
|
51.8 years
STANDARD_DEVIATION 13.41 • n=483 Participants
|
51.1 years
STANDARD_DEVIATION 12.62 • n=36 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
54 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
77 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
19 participants
n=4 Participants
|
17 participants
n=27 Participants
|
15 participants
n=483 Participants
|
69 participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=93 Participants
|
12 participants
n=4 Participants
|
17 participants
n=27 Participants
|
18 participants
n=483 Participants
|
62 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 84 daysOutcome measures
| Measure |
AIC246 (60 mg)
n=33 Participants
AIC246: Oral Administration
|
AIC246 (120 mg)
n=31 Participants
AIC246: Oral Administration
|
AIC246 (240 mg)
n=34 Participants
AIC246: Oral Administration
|
Placebo
n=33 Participants
Placebo: Oral Administration
|
|---|---|---|---|---|
|
Number of Participants With "HCMV Prophylaxis Failure"
|
16 Participants
|
10 Participants
|
10 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 84 daysOutcome measures
| Measure |
AIC246 (60 mg)
n=33 Participants
AIC246: Oral Administration
|
AIC246 (120 mg)
n=31 Participants
AIC246: Oral Administration
|
AIC246 (240 mg)
n=34 Participants
AIC246: Oral Administration
|
Placebo
n=33 Participants
Placebo: Oral Administration
|
|---|---|---|---|---|
|
Time to Onset of "HCMV Prophylaxis Failure"
|
7 days
|
6 days
|
2 days
|
12 days
|
SECONDARY outcome
Timeframe: 84 daysOutcome measures
| Measure |
AIC246 (60 mg)
n=33 Participants
AIC246: Oral Administration
|
AIC246 (120 mg)
n=31 Participants
AIC246: Oral Administration
|
AIC246 (240 mg)
n=34 Participants
AIC246: Oral Administration
|
Placebo
n=33 Participants
Placebo: Oral Administration
|
|---|---|---|---|---|
|
Number of Patients With Systemic Detectable HCMV Replication.
|
7 Participants
|
5 Participants
|
2 Participants
|
12 Participants
|
Adverse Events
AIC246 (60 mg)
Serious events: 13 serious events
Other events: 31 other events
Deaths: 2 deaths
AIC246 (120 mg)
Serious events: 15 serious events
Other events: 29 other events
Deaths: 1 deaths
AIC246 (240 mg)
Serious events: 12 serious events
Other events: 34 other events
Deaths: 1 deaths
Placebo
Serious events: 16 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
AIC246 (60 mg)
n=33 participants at risk
AIC246: Oral Administration
|
AIC246 (120 mg)
n=31 participants at risk
AIC246: Oral Administration
|
AIC246 (240 mg)
n=34 participants at risk
AIC246: Oral Administration
|
Placebo
n=33 participants at risk
Placebo: Oral Administration
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
6.1%
2/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Infections and infestations
Epstein-Barr Virus Infestcion
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Alcaligenes Infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Human Herpesvirus 6 Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Oral Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Sepsis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Septic Shock
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 2
|
|
Infections and infestations
Enterobacter Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia Recurrent
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma Recurrent
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia (in Remission)
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma Recurrent
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Immune system disorders
Acute Graft Versus Host Disease in Intestine
|
12.1%
4/33 • Number of events 4
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
|
Immune system disorders
Acute Graft Versus Host Disease in Liver
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Immune system disorders
Graft Versus Host Disease
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Immune system disorders
Acute Graft Versus Host Disease in Skin
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypoglykaemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Transplant Failure
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Cardiac disorders
Anginga Pectoris
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Atrial Fibrillation
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
General disorders
Generalised Oedema
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
General disorders
Pyrexia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
9.1%
3/33 • Number of events 3
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Liver Function Test
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Staphylococcus Test Positive
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Syncope
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Convulsion
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Hepatobiliary disorders
Venoocclusive Liver Disease
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
Other adverse events
| Measure |
AIC246 (60 mg)
n=33 participants at risk
AIC246: Oral Administration
|
AIC246 (120 mg)
n=31 participants at risk
AIC246: Oral Administration
|
AIC246 (240 mg)
n=34 participants at risk
AIC246: Oral Administration
|
Placebo
n=33 participants at risk
Placebo: Oral Administration
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Food Intolerance
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Haemosiderosis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
9/33 • Number of events 11
|
29.0%
9/31 • Number of events 11
|
32.4%
11/34 • Number of events 14
|
30.3%
10/33 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
21.2%
7/33 • Number of events 8
|
25.8%
8/31 • Number of events 16
|
20.6%
7/34 • Number of events 7
|
33.3%
11/33 • Number of events 11
|
|
Gastrointestinal disorders
Vomitting
|
12.1%
4/33 • Number of events 4
|
32.3%
10/31 • Number of events 11
|
23.5%
8/34 • Number of events 8
|
12.1%
4/33 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
12.1%
4/33 • Number of events 5
|
9.7%
3/31 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
3/33 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
15.2%
5/33 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 3
|
11.8%
4/34 • Number of events 4
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
11.8%
4/34 • Number of events 4
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
5.9%
2/34 • Number of events 3
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Gastrointestinal disorders
Dry Mouth
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
12.1%
4/33 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Proctalgia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Anorectal Discomfort
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Breath Odour
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Colitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Lip Dry
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Lip Swelling
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Lip Ulceration
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Oral Discomfort
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Swollen Tongue
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus Infection
|
18.2%
6/33 • Number of events 6
|
19.4%
6/31 • Number of events 6
|
14.7%
5/34 • Number of events 5
|
33.3%
11/33 • Number of events 11
|
|
Infections and infestations
Candidiasis
|
12.1%
4/33 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
0.00%
0/33
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.1%
2/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/33
|
0.00%
0/31
|
11.8%
4/34 • Number of events 4
|
0.00%
0/33
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Eppstein-Barr Virus Infection
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Pseudomonas Infection
|
6.1%
2/33 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33
|
9.7%
3/31 • Number of events 3
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Bacteraemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Folliculitis
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Infections and infestations
Oral Infection
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Staphylococcal Infection
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Eppstein-Barr Viraemia
|
3.0%
1/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Rhinitis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Alcaligenes Infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
BK Virus Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Body Tinea
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Bronchitis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Cystitis Viral
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Herpes Simplex
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Human Herpesvirus 6 Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Micrococcus Infection
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Oesphageal Candidiasis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Pharyngitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Pneumonia Herpes Viral
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Septic Shock
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Infections and infestations
Stenotrophomonas Infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Adenovirus Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus Viraemia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 2
|
|
Infections and infestations
Enterobacter Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Paronychia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Parotitis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Skin Infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Number of events 5
|
16.1%
5/31 • Number of events 7
|
11.8%
4/34 • Number of events 6
|
18.2%
6/33 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Puritus
|
6.1%
2/33 • Number of events 2
|
12.9%
4/31 • Number of events 4
|
14.7%
5/34 • Number of events 5
|
9.1%
3/33 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33
|
12.9%
4/31 • Number of events 5
|
11.8%
4/34 • Number of events 8
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.0%
1/33 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
3.0%
1/33 • Number of events 2
|
0.00%
0/31
|
2.9%
1/34 • Number of events 2
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 3
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Acute Febrile Neutrophilic Dermatosis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia Facial
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Lichenfication
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Palmar Eythema
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Perivascular Dermatitis
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Pruritis Generalised
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Morbilliform
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Fatigue
|
9.1%
3/33 • Number of events 6
|
25.8%
8/31 • Number of events 9
|
11.8%
4/34 • Number of events 6
|
15.2%
5/33 • Number of events 5
|
|
General disorders
Oedema Peripheral
|
12.1%
4/33 • Number of events 4
|
9.7%
3/31 • Number of events 3
|
23.5%
8/34 • Number of events 8
|
9.1%
3/33 • Number of events 3
|
|
General disorders
Pyrexia
|
9.1%
3/33 • Number of events 3
|
12.9%
4/31 • Number of events 4
|
14.7%
5/34 • Number of events 5
|
18.2%
6/33 • Number of events 6
|
|
General disorders
Oedema
|
3.0%
1/33 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
General disorders
Chills
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Catheter Site Erythema
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
General disorders
Catheter Site Pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
General disorders
Chest Pain
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
General disorders
Face Oedema
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
General disorders
Local Swelling
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Malaise
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
General disorders
Application Site Hypersensitivity
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Axillary Pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Gait Distrubance
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.1%
4/33 • Number of events 4
|
6.5%
2/31 • Number of events 2
|
14.7%
5/34 • Number of events 5
|
9.1%
3/33 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.1%
4/33 • Number of events 4
|
6.5%
2/31 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
3/33 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
1/33 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.0%
1/33 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • Number of events 2
|
25.8%
8/31 • Number of events 11
|
14.7%
5/34 • Number of events 5
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.1%
2/33 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
2/33 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Ebolism
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.1%
4/33 • Number of events 4
|
9.7%
3/31 • Number of events 3
|
23.5%
8/34 • Number of events 8
|
9.1%
3/33 • Number of events 3
|
|
Nervous system disorders
Neuropathy Peripheral
|
9.1%
3/33 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Tremor
|
3.0%
1/33 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Nervous system disorders
Polyneuropathy
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Somnolence
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Hypoaestesia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Restless Leg Syndrome
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Nervous system disorders
Syncope
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Nervous system disorders
Ageusia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
VIIth Nerve Paralysis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
2/33 • Number of events 2
|
12.9%
4/31 • Number of events 4
|
5.9%
2/34 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscles Spasms
|
3.0%
1/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
11.8%
4/34 • Number of events 6
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.1%
2/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • Number of events 3
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.1%
2/33 • Number of events 3
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Arthrophathy
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Mass
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Investigations
Hepatic Enzyme Increased
|
6.1%
2/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Investigations
Blood Creatinine Increased
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
|
Investigations
Alanine Aminotransferase Increased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
5.9%
2/34 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Blood Folate Decreased
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Investigations
Blood Urea Increased
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Red Blood Cell Morphology Abnormal
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Transaminases Increased
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Weight Decreased
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Blood Creatine Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Liver Function Test
|
3.0%
1/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Antithrombin III Decreased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Aspergillus Test Positive
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Blood Fibrinogen Decreased
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Blood Testosterone Decreased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
C-Reactive Protein Increased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Computerised Tomogram Abnormal
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Cytomegalovirus Test Positive
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
|
Investigations
Electrocardiogram QT Prolonged
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Electrocardiogram ST Segment Elevation
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Epstein-Barr Virus Test Positive
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Lipase Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Polyomavirus Test Positive
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Weight Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Investigations
Staphylococcus Test Positive
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Immune system disorders
Acute Graft Versus Host Disease
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 2
|
|
Renal and urinary disorders
Renal Failure
|
15.2%
5/33 • Number of events 5
|
16.1%
5/31 • Number of events 5
|
8.8%
3/34 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
0.00%
0/33
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Renal and urinary disorders
Inconinence
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 2
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Eye disorders
Dry Eye
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
14.7%
5/34 • Number of events 5
|
3.0%
1/33 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Eye disorders
Vision Blurred
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Eye disorders
Cataract
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Eye disorders
Eye Irritation
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Eye disorders
Conjuctival Hyperaemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Eye disorders
Eylid Oedema
|
3.0%
1/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Eye disorders
Eye Discharge
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Immune system disorders
Acute Graft Versus Host Disease in Skin
|
9.1%
3/33 • Number of events 4
|
16.1%
5/31 • Number of events 7
|
17.6%
6/34 • Number of events 7
|
6.1%
2/33 • Number of events 3
|
|
Immune system disorders
Acute Graft Versus Host Disease in Intestine
|
9.1%
3/33 • Number of events 3
|
0.00%
0/31
|
14.7%
5/34 • Number of events 6
|
12.1%
4/33 • Number of events 5
|
|
Immune system disorders
Graft Versus Host Disease
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Immune system disorders
Acute Graft Versus Host Disease in Liver
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
|
Immune system disorders
Drug Hypersensitivity
|
3.0%
1/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Immune system disorders
Chronic Graft Versus Host Disease
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Immune system disorders
Seasonal Allergy
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Eye disorders
Sicca Syndrome
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Eye disorders
Visual Impairment
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Eye disorders
Lagophthalmos
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
3/33 • Number of events 5
|
6.5%
2/31 • Number of events 2
|
11.8%
4/34 • Number of events 4
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.1%
2/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
8.8%
3/34 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.1%
2/33 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Splenomegaly
|
3.0%
1/33 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.0%
1/33 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Monocytosis
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
15.2%
5/33 • Number of events 5
|
12.9%
4/31 • Number of events 4
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Psychiatric disorders
Depression
|
9.1%
3/33 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/33
|
3.2%
1/31 • Number of events 2
|
0.00%
0/34
|
0.00%
0/33
|
|
Psychiatric disorders
Decreased Activitiy
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Psychiatric disorders
Delirium
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Psychiatric disorders
Panick Attack
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Psychiatric disorders
Stress
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Adjustment Disorders
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Fear
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 2
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/33
|
6.5%
2/31 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
2/33 • Number of events 2
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
8.8%
3/34 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Vascular disorders
Deep Vain Thrombosis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Vascular disorders
Flushing
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Vascular disorders
Hot Flush
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Vascular disorders
Ischaemia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Vascular disorders
Varicophlebitis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
3.0%
1/33 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia Recurrent
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma Recurrent
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia (in Remission)
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr Virus Associated Lymphoproliferative Disorder
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
6.1%
2/33 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
0.00%
0/34
|
0.00%
0/33
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Pericardial Effusion
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Sinus Arrhythmia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Atropic Vulvovaginitis
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Genital Lesion
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Scrotal Erythema
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Reproductive system and breast disorders
Breast Swelling
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.0%
1/33 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Hepatobiliary disorders
Cholestasis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Hepatobiliary disorders
Venoocclusive Liver Disease
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Endocrine disorders
Thyroid Disorder
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Auricular Swelling
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/34
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
1/33 • Number of events 1
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Dysacusis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Congestion
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Ear and labyrinth disorders
Inner Ear Inflammation
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
|
Congenital, familial and genetic disorders
Chimerism
|
0.00%
0/33
|
0.00%
0/31
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
Additional Information
Chief Medical Officer
AiCuris Anti-infective Cures GmbH
Phone: 004920231763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER