Trial Outcomes & Findings for Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis (NCT NCT00404092)
NCT ID: NCT00404092
Last Updated: 2013-07-31
Results Overview
Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)
Results posted on
2013-07-31
Participant Flow
Participant milestones
| Measure |
1st Cohort
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
200mg 1x/day
caspofungin : i.v.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
9
|
20
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
1st Cohort
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
200mg 1x/day
caspofungin : i.v.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
Baseline characteristics by cohort
| Measure |
1st Cohort
n=9 Participants
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
n=8 Participants
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
n=9 Participants
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
n=20 Participants
200mg 1x/day
caspofungin : i.v.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=30 years
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Age, Customized
Between 30 and 40 years
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Age, Customized
Between 40 and 50 years
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Age, Customized
Between 50 and 60 years
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
7 participants
n=36 Participants
|
|
Age, Customized
Between 60 and 70 years
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
7 participants
n=483 Participants
|
17 participants
n=36 Participants
|
|
Age, Customized
> 70 years
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
5 participants
n=483 Participants
|
8 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=93 Participants
|
8 participants
n=4 Participants
|
9 participants
n=27 Participants
|
20 participants
n=483 Participants
|
46 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.
Outcome measures
| Measure |
1st Cohort
n=9 Participants
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
n=7 Participants
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
n=8 Participants
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
n=20 Participants
200mg 1x/day
caspofungin : i.v.
|
|---|---|---|---|---|
|
Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis
Treatment-emergent AEs (grade 3 to 5)
|
11 events
|
12 events
|
9 events
|
73 events
|
|
Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis
At least possibly related AEs (grade 3 to 5)
|
0 events
|
0 events
|
0 events
|
6 events
|
|
Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis
At least probably related AEs (grade 3 to 5)
|
0 events
|
0 events
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-upPopulation: All 46 recruited patients were included in the analysis. 2 (EOT), 16 (4w FU) and 23 (12w FU) outcomes out of 46 were not recorded.
Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU. Definitions: CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities. PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities. Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities. Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death. Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal.
Outcome measures
| Measure |
1st Cohort
n=9 Participants
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
n=8 Participants
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
n=9 Participants
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
n=20 Participants
200mg 1x/day
caspofungin : i.v.
|
|---|---|---|---|---|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Relapse (from Favorable Response) 12w post EOT
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Favorable Response (CR&PR)
|
4 participants
|
3 participants
|
6 participants
|
12 participants
|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Complete Response (CR)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Partial Response (PR)
|
4 participants
|
3 participants
|
5 participants
|
12 participants
|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Stable Disease
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Failure
|
3 participants
|
4 participants
|
0 participants
|
8 participants
|
|
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
Relapse (from Favorable Response) 4w post EOT
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
Adverse Events
1st Cohort
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
2nd Cohort
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
3rd Cohort
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
4th Cohort
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1st Cohort
n=9 participants at risk
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
n=8 participants at risk
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
n=9 participants at risk
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
n=20 participants at risk
200mg 1x/day
caspofungin : i.v.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Syncope
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Infections and infestations
Sepsis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
15.0%
3/20
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9
|
37.5%
3/8
|
11.1%
1/9
|
15.0%
3/20
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
General disorders
Fever
|
0.00%
0/9
|
0.00%
0/8
|
44.4%
4/9
|
15.0%
3/20
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
General disorders
Worsening of general condition
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
Death
|
11.1%
1/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
General disorders
Persistence or progression of underlying disease
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
20.0%
4/20
|
|
Surgical and medical procedures
Urinary bladder tamponade
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
Other adverse events
| Measure |
1st Cohort
n=9 participants at risk
70mg 1x/day
caspofungin : i.v.
|
2nd Cohort
n=8 participants at risk
100mg 1x/day
caspofungin : i.v.
|
3rd Cohort
n=9 participants at risk
150mg 1x/day
caspofungin : i.v.
|
4th Cohort
n=20 participants at risk
200mg 1x/day
caspofungin : i.v.
|
|---|---|---|---|---|
|
Renal and urinary disorders
urinary bleeding
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Hepatobiliary disorders
elevated bilirubin
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
elevated liver test (alt)
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
high ALT
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Hepatobiliary disorders
high AP
|
22.2%
2/9
|
0.00%
0/8
|
11.1%
1/9
|
30.0%
6/20
|
|
Hepatobiliary disorders
high AST
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
high billirubin
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Hepatobiliary disorders
high direct bilirubin
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
high gGT
|
44.4%
4/9
|
0.00%
0/8
|
0.00%
0/9
|
25.0%
5/20
|
|
Hepatobiliary disorders
high GPT
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Hepatobiliary disorders
high total bilirubin
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
intermittant elevated alt
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
low cholinesterase
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
low pancreas amylase
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Infections and infestations
febrile neutropenia
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Infections and infestations
fever
|
22.2%
2/9
|
37.5%
3/8
|
11.1%
1/9
|
15.0%
3/20
|
|
Infections and infestations
fever in neutropenia
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Infections and infestations
herpes infection
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Infections and infestations
herpes simplex infection lips
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Infections and infestations
high procalcitonin
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Infections and infestations
infection at the puncture of central ven
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Infections and infestations
infection of puncture at central venous
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Infections and infestations
infection with staphylococcus
|
0.00%
0/9
|
0.00%
0/8
|
33.3%
3/9
|
0.00%
0/20
|
|
Infections and infestations
infection with streptococcus mitis
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Infections and infestations
klebsiella detection in sputum
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Infections and infestations
rhinitis
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Infections and infestations
swelling of the mucosa at the bottom of
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Infections and infestations
thrombophlebitis
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Infections and infestations
urethritis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
15.0%
3/20
|
|
Injury, poisoning and procedural complications
hematoma due to blood sampling
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
hematoma left arm
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
hemorrhoids bleeding
|
0.00%
0/9
|
12.5%
1/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
nosebleed
|
11.1%
1/9
|
25.0%
2/8
|
22.2%
2/9
|
10.0%
2/20
|
|
Blood and lymphatic system disorders
petechiae
|
22.2%
2/9
|
0.00%
0/8
|
44.4%
4/9
|
10.0%
2/20
|
|
Blood and lymphatic system disorders
red spots at the lower abdominal area
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
red spots, pustules
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
redness and bleeding of anus
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
heartburn
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
inappetance
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
inappetence
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
mucositis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
nausea
|
22.2%
2/9
|
37.5%
3/8
|
11.1%
1/9
|
25.0%
5/20
|
|
Gastrointestinal disorders
obstipation
|
22.2%
2/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
oral lesions due to dental prosthesis
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
pain during swallowing
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
red-brown coated tongue
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
sialorrhea
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
sore throat
|
0.00%
0/9
|
0.00%
0/8
|
22.2%
2/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
swallow pain
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
vomiting
|
22.2%
2/9
|
37.5%
3/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Gastrointestinal disorders
xerostomia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Gastrointestinal disorders
yellow coated tongue
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
bleeding at puncture
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
15.0%
3/20
|
|
Injury, poisoning and procedural complications
bleeding operation wound left shoulder
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
bloody sputum
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysen
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
hematoma
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
hematoma at the neck
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Ear and labyrinth disorders
intermittant ear pressure
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Ear and labyrinth disorders
pressure on the ears
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
55.0%
11/20
|
|
Blood and lymphatic system disorders
intermittend leukopenia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
intermittend thrombocytopenia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
leukopenia
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
neutropenia
|
33.3%
3/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
persistence of blast cells
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
persistence of blasts
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
thrombopenia
|
0.00%
0/9
|
12.5%
1/8
|
11.1%
1/9
|
15.0%
3/20
|
|
Cardiac disorders
arterial hypertension
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
cardiac dysrrhthmias
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
circulatory discomfort
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Cardiac disorders
collaps
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
cyanosis
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Cardiac disorders
edema
|
55.6%
5/9
|
12.5%
1/8
|
22.2%
2/9
|
20.0%
4/20
|
|
Cardiac disorders
fall, knocked head
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Cardiac disorders
heart-trouble
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Cardiac disorders
hypertension
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
15.0%
3/20
|
|
Cardiac disorders
hypotension
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
hypotension with dizziness
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Cardiac disorders
hypotonia
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Cardiac disorders
tachycardia
|
0.00%
0/9
|
12.5%
1/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Cardiac disorders
tightness in the chest
|
0.00%
0/9
|
12.5%
1/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Cardiac disorders
vertigo
|
11.1%
1/9
|
12.5%
1/8
|
22.2%
2/9
|
5.0%
1/20
|
|
Vascular disorders
thrombosis left leg
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
fatigue
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
General disorders
fatique
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
General disorders
loss of weight
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
night sweat
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
2/20
|
|
General disorders
perspiration
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
General disorders
sweating
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
weakness
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Injury, poisoning and procedural complications
aching of the intravenuos line
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
cavernoma left occipital cerebrum
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
croakiness
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
dry nose
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Infections and infestations
flu-like symptoms
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
frequent dejection
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
gain of weight
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Renal and urinary disorders
haemorrhagic cystitis
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
hair loss
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
hardening of arm/leg
|
11.1%
1/9
|
0.00%
0/8
|
22.2%
2/9
|
0.00%
0/20
|
|
Ear and labyrinth disorders
hearing loss
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
high gammaglobuline/alpha-1-globuline
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Hepatobiliary disorders
high LDH
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
decubitus ulcer both ears
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
itching
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/9
|
12.5%
1/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
pruritus at the eyelids
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
3/9
|
0.00%
0/8
|
22.2%
2/9
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
reddened hands
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
redness at puncture
|
11.1%
1/9
|
12.5%
1/8
|
22.2%
2/9
|
25.0%
5/20
|
|
Skin and subcutaneous tissue disorders
redness of eyelid
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
redness on backside
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
swelling of arm/leg
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
aphtha
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
brown coated tongue
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
coated tongue
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
diarrhea
|
11.1%
1/9
|
12.5%
1/8
|
44.4%
4/9
|
30.0%
6/20
|
|
Gastrointestinal disorders
discomfort over the liver area
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
dry lips
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
dry mucosa mouth
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Hepatobiliary disorders
alkaline phophatase increase
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Renal and urinary disorders
elevated uric acid
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Renal and urinary disorders
high creatinine
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Renal and urinary disorders
high urea
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Renal and urinary disorders
high uric acid
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
hypalbuminemia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
hypercalcelmia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
hyperchloridemia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
hyperglykemia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
20.0%
4/20
|
|
Metabolism and nutrition disorders
hyperkalemia
|
22.2%
2/9
|
0.00%
0/8
|
11.1%
1/9
|
25.0%
5/20
|
|
Metabolism and nutrition disorders
hypernatremia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Renal and urinary disorders
hyperuricemia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
hyperventilation
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
hypocalcemia
|
0.00%
0/9
|
37.5%
3/8
|
0.00%
0/9
|
25.0%
5/20
|
|
Metabolism and nutrition disorders
hypokalemia
|
11.1%
1/9
|
25.0%
2/8
|
22.2%
2/9
|
30.0%
6/20
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
intermittant hypoalbuminia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
intermittent hyponatremia
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
low albumin
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
low albumine
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
low protein
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
calf cramps
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
swelling of arm/leg
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Psychiatric disorders
amentia
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Nervous system disorders
confusion
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
hallucination
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
intermittant sleep disturbance
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Nervous system disorders
intermittend sleeping disorder
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
neuropathia aboth arms
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
paraesthesia (fingers)
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
paraesthesia (limbs, lips, fingers)
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
patient not addressable
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
prickle and numbness in both feet
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Nervous system disorders
restlessness
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
sleep disturbance
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Nervous system disorders
slight drowsiness during caspofungin inf
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
small pupils
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
tremor
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
viewing of colours
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Nervous system disorders
worsening of visual acuity
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Eye disorders
reddened eyes
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Infections and infestations
ague
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
backache
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
bonepain
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
General disorders
flank pain
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Nervous system disorders
headache
|
22.2%
2/9
|
25.0%
2/8
|
22.2%
2/9
|
10.0%
2/20
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
kneepain
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
neck aches
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
neck ache
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
neck pain (osteoporosis)
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
neck stiffness
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
pain at puncture of the central venous c
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
pain at the costal arch
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
pain in the left arm
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Gastrointestinal disorders
pain in thorax and abdomen
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
pain left calf
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
pain left upper arm
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
pain on central venous catheder punction
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
General disorders
pain stomach left site
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
painful peripheral catheter punktion pla
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
painful shoulder
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
pressure pain on the fingernails
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
slight backpain
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
thoracic pain
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasms
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
3/9
|
12.5%
1/8
|
11.1%
1/9
|
15.0%
3/20
|
|
Respiratory, thoracic and mediastinal disorders
cough, bloody sputum
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
11.1%
1/9
|
37.5%
3/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
hoarse voice
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
local pneumothorax
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
nasal discharge
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
pain int the lungs
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
pain while breathing
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
patients feels like he has a common cold
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
stridor
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
worsening of breathing
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
yellow expectoration
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/20
|
|
Renal and urinary disorders
acute renal failure
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Renal and urinary disorders
pollakisuria
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
|
Renal and urinary disorders
polyuria
|
0.00%
0/9
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/20
|
|
Renal and urinary disorders
reduced urine production
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/9
|
5.0%
1/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place