Trial Outcomes & Findings for Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL) (NCT NCT01191541)
NCT ID: NCT01191541
Last Updated: 2021-08-10
Results Overview
We assessed the OS of APL patients when ATRA and ATO were used. The overall survival (OS) durations was calculated from the date of diagnosis to last follow-up or death.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
two years
Results posted on
2021-08-10
Participant Flow
Eligible patients were those who were less than 14 years old, were newly diagnosed with APL, and had not previously received chemotherapy. Sixty-five patients were included in the study.
The demonstration of PML-RARA transcripts, was required for inclusion in the analysis.
Participant milestones
| Measure |
Daunorubicin(DNR)+Ara-c (Ara-C Group)
one group treated with daunorubicin(DNR)+Ara-C in consolidation
|
DNR (No Ara-c Group)
Only DNR was used in consolidation
|
|---|---|---|
|
All the Patients
STARTED
|
30
|
35
|
|
All the Patients
COMPLETED
|
30
|
35
|
|
All the Patients
NOT COMPLETED
|
0
|
0
|
|
the Randomized Patients
STARTED
|
30
|
35
|
|
the Randomized Patients
COMPLETED
|
30
|
35
|
|
the Randomized Patients
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
Baseline characteristics by cohort
| Measure |
DNR+Ara-c
n=30 Participants
one group treated with DNR+Ara-C
|
DNR（ no Ara-C)
n=35 Participants
one group treated with DNR
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
8 years
n=93 Participants
|
7 years
n=4 Participants
|
8 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
35 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
65 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=4 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
0 Participants
n=27 Participants • Between May 2010 and December 2016, 65 consecutive patients with genetically confirmed newly diagnosed APL patients (≤14years) were admitted in our hospital.
|
|
Region of Enrollment
China
|
30 participants
n=93 Participants
|
35 participants
n=4 Participants
|
65 participants
n=27 Participants
|
|
white blood cell count
|
4.23 cells x 10^9/L
n=93 Participants
|
5.47 cells x 10^9/L
n=4 Participants
|
4.71 cells x 10^9/L
n=27 Participants
|
|
Haemoglobin
|
78 g/L
n=93 Participants
|
81.0 g/L
n=4 Participants
|
78 g/L
n=27 Participants
|
|
Platelet count
|
24.5 cells x 10^9/L
n=93 Participants
|
32.0 cells x 10^9/L
n=4 Participants
|
30.5 cells x 10^9/L
n=27 Participants
|
PRIMARY outcome
Timeframe: two yearsPopulation: There were 65 patients included in our study, including 35 in the DNR group and 30 in the DNR+Ara-C group.
We assessed the OS of APL patients when ATRA and ATO were used. The overall survival (OS) durations was calculated from the date of diagnosis to last follow-up or death.
Outcome measures
| Measure |
DNR Group
n=35 Participants
the patients in this group were treated with DNR alone in consolidation
|
DNR+Ara-C Group
n=30 Participants
the patients in this group were treated with DNR +Ara-C in consolidation
|
|---|---|---|
|
the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
relapse
|
1 participants
|
0 participants
|
|
the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
died
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: There were 65 patients included in our study, including 35 in the DNR group and 30 in the DNR+Ara-C group.
We assessed the EFS of APL patients treated with retinoic acid receptor alpha (ATRA) and Arsenic Trioxide (ATO) based trial. Event-free survival (EFS) was defined as time from diagnosis to last follow-up or an event (relapse or death).
Outcome measures
| Measure |
DNR Group
n=30 Participants
the patients in this group were treated with DNR alone in consolidation
|
DNR+Ara-C Group
n=35 Participants
the patients in this group were treated with DNR +Ara-C in consolidation
|
|---|---|---|
|
the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
relapse
|
0 participants
|
1 participants
|
|
the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
die
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: three yearsPopulation: There were 66 patients included in our study. One patient gave up treatment due to the economic reasons. Then the number of the patients were 65, including 35 in the DNR group and 30 in the DNR+Ara-C group.
Also, we compared the side effect and outcome between the two groups.To assessed whether Ara-C could be omitted when ATO and ATRA were used.
Outcome measures
| Measure |
DNR Group
n=30 Participants
the patients in this group were treated with DNR alone in consolidation
|
DNR+Ara-C Group
n=35 Participants
the patients in this group were treated with DNR +Ara-C in consolidation
|
|---|---|---|
|
Number of Participants With Side Effects
sepsis
|
5 Participants
|
1 Participants
|
|
Number of Participants With Side Effects
platelet transfusion
|
26 Participants
|
0 Participants
|
|
Number of Participants With Side Effects
red blood cell transfusion
|
7 Participants
|
7 Participants
|
|
Number of Participants With Side Effects
relapse
|
0 Participants
|
1 Participants
|
Adverse Events
All the Patients at Presentation
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
the Adverse Events Associated With ATRA
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
the Adverse Events Associated With ATO
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Consolidation: IDA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Consolidation: ATO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Consolidation: DNR (No Ara-c Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Consolidation: DNR+Ara-c (Ara-C Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maintenance: ATRA+MTX+6-MP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All the Patients at Presentation
n=65 participants at risk
Between May 2010 and December 2016, 65 consecutive paediatric (≤14 years of age) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.
|
the Adverse Events Associated With ATRA
n=65 participants at risk
There were 65 patients were treated with ATRA and ATO in induction.
|
the Adverse Events Associated With ATO
n=65 participants at risk
There were 65 patients were treated with ATRA and ATO in induction.
|
Consolidation: IDA
n=65 participants at risk
There were 65 patients were treated with IDA in consolidation. .
|
Consolidation: ATO
n=65 participants at risk
There were 65 patients were treated with ATO in consolidation.
|
Consolidation: DNR (No Ara-c Group)
n=35 participants at risk
There were 35 patients were treated with DNR in consolidation.
|
Consolidation: DNR+Ara-c (Ara-C Group)
n=30 participants at risk
There were 30 patients were treated with DNR+ARA-C in consolidation.
|
Maintenance: ATRA+MTX+6-MP
n=65 participants at risk
There were 65 patients were treated with maintenance.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
intracranial bleeding
|
6.2%
4/65 • Number of events 4 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Eye disorders
intraocular bleeding
|
9.2%
6/65 • Number of events 6 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Vascular disorders
mild partial splenic embolization
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Blood and lymphatic system disorders
retinoic acid syndrome
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Cardiac disorders
cardiac arrhythmia
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
1.5%
1/65 • Number of events 1 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
Other adverse events
| Measure |
All the Patients at Presentation
n=65 participants at risk
Between May 2010 and December 2016, 65 consecutive paediatric (≤14 years of age) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.
|
the Adverse Events Associated With ATRA
n=65 participants at risk
There were 65 patients were treated with ATRA and ATO in induction.
|
the Adverse Events Associated With ATO
n=65 participants at risk
There were 65 patients were treated with ATRA and ATO in induction.
|
Consolidation: IDA
n=65 participants at risk
There were 65 patients were treated with IDA in consolidation. .
|
Consolidation: ATO
n=65 participants at risk
There were 65 patients were treated with ATO in consolidation.
|
Consolidation: DNR (No Ara-c Group)
n=35 participants at risk
There were 35 patients were treated with DNR in consolidation.
|
Consolidation: DNR+Ara-c (Ara-C Group)
n=30 participants at risk
There were 30 patients were treated with DNR+ARA-C in consolidation.
|
Maintenance: ATRA+MTX+6-MP
n=65 participants at risk
There were 65 patients were treated with maintenance.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
extremity oedema
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
13.8%
9/65 • Number of events 9 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
10.8%
7/65 • Number of events 7 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Skin and subcutaneous tissue disorders
skin pigmentation
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
10.8%
7/65 • Number of events 7 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Musculoskeletal and connective tissue disorders
bone ache
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
12.3%
8/65 • Number of events 8 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Cardiac disorders
asymptomatic QTc prolongation
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
General disorders
headache
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
36.9%
24/65 • Number of events 24 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
3.1%
2/65 • Number of events 2 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Blood and lymphatic system disorders
retinoic acid syndrome
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
10.8%
7/65 • Number of events 7 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
|
Hepatobiliary disorders
hepatotoxicity
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
6.2%
4/65 • Number of events 4 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
4.6%
3/65 • Number of events 3 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/35 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/30 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
0.00%
0/65 • Between May 2010 and December 2016, 65 consecutive paediatric (≤14years old) patients who were genetically confirmed with a new diagnosis of APL were admitted in our hospital.The follow-up of the patients was updated on Jan 2017 and included a median of 32 months (range, 1 to 79). The adverse event data were collected from the patient enrolled in our trials.The median period of time were 32 months (range, 1 to 79).
All adverse events described were founded during the course of induction therapy.
|
Additional Information
xiaofan Zhu
Department of pediatrics, Institute of Hematology and Blood Diseases Hospital.
Phone: +86 22 23909001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place