Trial Outcomes & Findings for Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells (NCT NCT00398411)
NCT ID: NCT00398411
Last Updated: 2015-06-29
Results Overview
Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Results posted on
2015-06-29
Participant Flow
First patient in: Oct 10, 2006; Last patient, last visit: Dec 08, 2008
68 patients were intended for inclusion in the trial. Two patients were excluded due to violation of inclusion/exclusion criteria; both received no study drug and they were excluded from the analysis. The remaining 66 participants were evaluable for response analysis in the intention to treat (ITT) set.
Participant milestones
| Measure |
Moxifloxacin
moxifloxacin 400 mg tablets once daily
|
Placebo
identical appearing placebo
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
34
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Moxifloxacin
moxifloxacin 400 mg tablets once daily
|
Placebo
identical appearing placebo
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Baseline characteristics by cohort
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
50 years
n=7 Participants
|
51.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Height
|
172.71 cm
STANDARD_DEVIATION 8.7 • n=5 Participants
|
173.72 cm
STANDARD_DEVIATION 9.7 • n=7 Participants
|
173.2 cm
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Weight
|
76.41 kg
STANDARD_DEVIATION 13.9 • n=5 Participants
|
75.00 kg
STANDARD_DEVIATION 16.5 • n=7 Participants
|
75.73 kg
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Underlying Disease
Hodgkin's Disease
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Underlying Disease
NHL
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Underlying Disease
Multiple Myeloma
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Underlying Disease
Solid Tumor
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Status of Underlying Disease
primary
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Status of Underlying Disease
primary progressive
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Status of Underlying Disease
relapsed
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)Population: intention to treat (ITT)
Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.
Outcome measures
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
|---|---|---|
|
Incidence of Clinically Significant Bacteremia
|
3 participants
|
9 participants
|
SECONDARY outcome
Timeframe: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)Population: intention to treat (ITT)
Outcome measures
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
|---|---|---|
|
Type of Isolates and Infections
bacteremia isolate: enterococcus faecalis
|
0 participants
|
2 participants
|
|
Type of Isolates and Infections
bacteremia isolate: escherichia coli
|
1 participants
|
3 participants
|
|
Type of Isolates and Infections
bacteremia isolate: klebsiella pneumoniae
|
0 participants
|
1 participants
|
|
Type of Isolates and Infections
bacteremia isolate: pseudomonas aeruginosa
|
1 participants
|
0 participants
|
|
Type of Isolates and Infections
bacteremia isolate: staphylococcus aureus
|
1 participants
|
1 participants
|
|
Type of Isolates and Infections
bacteremia isolate: staphylococcus epidermidis
|
0 participants
|
1 participants
|
|
Type of Isolates and Infections
bacteremia isolate: streptococcus species
|
0 participants
|
1 participants
|
|
Type of Isolates and Infections
clostridium difficile infection
|
1 participants
|
1 participants
|
|
Type of Isolates and Infections
mucositis
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)Population: intention to treat (ITT)
Outcome measures
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
|---|---|---|
|
Time to Occurrence of Fever >= 38°C
|
9.50 days
Standard Deviation 4.1
|
7.69 days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)Population: intention to treat (ITT)
Absolute neutrophil count (ANC) recovered to \> 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever \>= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason
Outcome measures
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
|---|---|---|
|
Reason for Discontinuation of Treatment
premature discontinuation: other adverse event
|
6 participants
|
2 participants
|
|
Reason for Discontinuation of Treatment
recovery of absolute neutrophil count
|
6 participants
|
0 participants
|
|
Reason for Discontinuation of Treatment
maximum of 20 days of treatment
|
0 participants
|
0 participants
|
|
Reason for Discontinuation of Treatment
premature discontinuation: occurence of fever
|
18 participants
|
23 participants
|
|
Reason for Discontinuation of Treatment
premature discontinuation: antibiotic treatment
|
1 participants
|
1 participants
|
|
Reason for Discontinuation of Treatment
premature discontinuation: death
|
0 participants
|
1 participants
|
|
Reason for Discontinuation of Treatment
premature discontinuation: other reason
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)Population: intention to treat (ITT)
Outcome measures
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
|---|---|---|
|
Type of Infection
peri-anal abscess
|
0 participants
|
1 participants
|
|
Type of Infection
mucositis
|
1 participants
|
1 participants
|
|
Type of Infection
pulmonary infiltrate
|
1 participants
|
0 participants
|
|
Type of Infection
infection at venous catheter
|
1 participants
|
1 participants
|
|
Type of Infection
herpes infection
|
8 participants
|
8 participants
|
|
Type of Infection
candida infection
|
1 participants
|
0 participants
|
|
Type of Infection
acute respiratory syndrome
|
1 participants
|
0 participants
|
|
Type of Infection
clostridium difficile infection
|
0 participants
|
1 participants
|
|
Type of Infection
atypical pneumonia
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)Population: intention to treat (ITT)
Outcome measures
| Measure |
Moxifloxacin
n=34 Participants
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 Participants
identical appearing placebo
|
|---|---|---|
|
Overall Survival
|
34 participants
|
31 participants
|
Adverse Events
Moxifloxacin
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moxifloxacin
n=34 participants at risk
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 participants at risk
identical appearing placebo
|
|---|---|---|
|
Infections and infestations
atypical pneumonia
|
2.9%
1/34 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
0.00%
0/32 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/34 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
3.1%
1/32 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Hepatobiliary disorders
cholecystitis
|
2.9%
1/34 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
0.00%
0/32 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Infections and infestations
clostridium difficile infection
|
0.00%
0/34 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
3.1%
1/32 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Infections and infestations
staphyloccocus epidermidis sepsis
|
0.00%
0/34 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
3.1%
1/32 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
Other adverse events
| Measure |
Moxifloxacin
n=34 participants at risk
moxifloxacin 400 mg tablets once daily
|
Placebo
n=32 participants at risk
identical appearing placebo
|
|---|---|---|
|
General disorders
abdominal cramps
|
5.9%
2/34 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
3.1%
1/32 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.9%
2/34 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
3.1%
1/32 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Gastrointestinal disorders
constipation
|
23.5%
8/34 • Number of events 8 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
21.9%
7/32 • Number of events 7 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
14.7%
5/34 • Number of events 5 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
18.8%
6/32 • Number of events 6 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Musculoskeletal and connective tissue disorders
cramps in the calf
|
2.9%
1/34 • Number of events 1 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
6.2%
2/32 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Gastrointestinal disorders
diarrhea
|
76.5%
26/34 • Number of events 36 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
65.6%
21/32 • Number of events 23 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Renal and urinary disorders
dysuria
|
5.9%
2/34 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
9.4%
3/32 • Number of events 3 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
General disorders
edema
|
76.5%
26/34 • Number of events 37 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
81.2%
26/32 • Number of events 42 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Skin and subcutaneous tissue disorders
exanthema
|
20.6%
7/34 • Number of events 7 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
18.8%
6/32 • Number of events 6 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Infections and infestations
fever
|
79.4%
27/34 • Number of events 35 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
96.9%
31/32 • Number of events 45 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
General disorders
headache
|
29.4%
10/34 • Number of events 13 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
31.2%
10/32 • Number of events 11 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Gastrointestinal disorders
heartburn / reflux
|
17.6%
6/34 • Number of events 6 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
6.2%
2/32 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Vascular disorders
hypertension
|
5.9%
2/34 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
9.4%
3/32 • Number of events 4 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
General disorders
hypokalemia
|
73.5%
25/34 • Number of events 35 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
68.8%
22/32 • Number of events 28 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
General disorders
hyponatremia
|
8.8%
3/34 • Number of events 3 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
6.2%
2/32 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Vascular disorders
hypotension
|
8.8%
3/34 • Number of events 3 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
21.9%
7/32 • Number of events 7 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Blood and lymphatic system disorders
increase of CRP
|
23.5%
8/34 • Number of events 8 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
12.5%
4/32 • Number of events 4 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Hepatobiliary disorders
increase of bilirubin
|
8.8%
3/34 • Number of events 4 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
6.2%
2/32 • Number of events 4 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Renal and urinary disorders
increase of creatinine
|
0.00%
0/34 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
6.2%
2/32 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Hepatobiliary disorders
increase of liver enzymes
|
29.4%
10/34 • Number of events 20 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
40.6%
13/32 • Number of events 25 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Gastrointestinal disorders
nausea
|
91.2%
31/34 • Number of events 52 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
75.0%
24/32 • Number of events 42 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/34 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
6.2%
2/32 • Number of events 2 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
|
Gastrointestinal disorders
vomiting
|
70.6%
24/34 • Number of events 32 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
62.5%
20/32 • Number of events 32 • Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE: Infections, already reported as outcome measures. Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place