Trial Outcomes & Findings for GRASPA Treatment for Patients With Acute Myeloblastic Leukemia (NCT NCT01810705)
NCT ID: NCT01810705
Last Updated: 2022-02-21
Results Overview
OS is defined as the time elapsed between randomization and death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Each patient will be followed for a duration of 24 months.
Results posted on
2022-02-21
Participant Flow
Participant milestones
| Measure |
GRASPA
patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm "Control")
GRASPA: Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum
|
Control
patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
40
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
73
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GRASPA
n=83 Participants
In the experimental group, the patients will receive one administration of GRASPA (100 IU/kg) at Day 11 in combination with subcutaneous low-dose cytarabine as 40 mg daily (either one single dose of 40 mg or 20 mg twice daily according to local practice) for 10 consecutive days, every 28 days, for duration up to 24 months
|
Control
n=40 Participants
In the control arm, patients will be treated with subcutaneous low-dose cytarabine as 40 mg daily (either one single dose of 40 mg or 20 mg twice daily according to local practice) for 10 consecutive days, every 28 days, for duration up to 24 months. Each period of 28 days constitute a cycle of chemotherapy.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=83 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=83 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=83 Participants
|
40 Participants
n=40 Participants
|
123 Participants
n=123 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=83 Participants
|
16 Participants
n=40 Participants
|
53 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=83 Participants
|
24 Participants
n=40 Participants
|
70 Participants
n=123 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Population: OS was to be assessed by measuring time elapsed between randomisation and death for any cause. Any patient not known to have died at the time of analysis is censored based on the last recorded date on which the patient was known to be alive
OS is defined as the time elapsed between randomization and death from any cause.
Outcome measures
| Measure |
GRASPA
n=83 Participants
patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm "Control")
GRASPA: Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum
|
Control
n=40 Participants
patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months
|
|---|---|---|
|
Overall Survival
|
4.8 months
Interval 3.1 to 7.0
|
6.4 months
Interval 3.6 to 10.7
|
SECONDARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Percentage of patients with Complete remission (CR), Complete remission with incomplete recovery (neutrophil or platelet regeneration, CRi), Partial remission (PR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Defined as the time elapsed between randomization and resistant disease or relapse or death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Collecting survey about patients quality of life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Number of incidences, type, severity and causality of adverse events / serious adverse events
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Defined only for patients who achieve CR or CRi as the time elapsed between date of CR/CRi and date of disease relapse or death from any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Each patient will be followed for a duration of 24 months.Hospitalizations (except schedule protocol visit during the study)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until patient stops treatment (expected average of 8 months)Number of transfusions per patient (red blood cells and or platelets)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until patient stops treatment (expected average of 8 months)Plasma concentrations of asparagine, aspartate, glutamine, glutamate, whole blood L- asparaginase activity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until patient stops treatment (expected average of 8 months)Titer of anti L-asparaginase antibodies
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until patient stops treatment (expected average of 8 months)Asparagine synthetase and in vitro sensitivity to aspariginase on the harvested bone marrow cells
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until patient stops treatment (expected average of 8 months)Defined as cytogenetic biomarker testing
Outcome measures
Outcome data not reported
Adverse Events
GRASPA
Serious events: 74 serious events
Other events: 80 other events
Deaths: 70 deaths
Control
Serious events: 32 serious events
Other events: 39 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
GRASPA
n=81 participants at risk
Patients having received at least one injection of GRASPA (100 IU/kg) i.e. 81 in GRASPA arm
|
Control
n=39 participants at risk
Patients having received at least one dose of study treatment i.e. 39 in control arm
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
7.4%
6/81 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
0.00%
0/39 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
7.4%
6/81 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
9.9%
8/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.6%
7/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
7/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Hemorrhagic Events
|
7.4%
6/81 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.2%
5/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
General physical health deterioration
|
12.3%
10/81 • Number of events 12 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
Pyrexia
|
8.6%
7/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Infections and infestations
Sepsis
|
14.8%
12/81 • Number of events 13 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Infections and infestations
Septic shock
|
8.6%
7/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
4.9%
4/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Infections and infestations
Lung infection
|
1.2%
1/81 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Infections and infestations
Infection
|
0.00%
0/81 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
Other adverse events
| Measure |
GRASPA
n=81 participants at risk
Patients having received at least one injection of GRASPA (100 IU/kg) i.e. 81 in GRASPA arm
|
Control
n=39 participants at risk
Patients having received at least one dose of study treatment i.e. 39 in control arm
|
|---|---|---|
|
Immune system disorders
Alloimmunisation
|
19.8%
16/81 • Number of events 16 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Immune system disorders
Hypersensitivity
|
9.9%
8/81 • Number of events 14 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
0.00%
0/39 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
asthenia
|
16.0%
13/81 • Number of events 17 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
23.1%
9/39 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
Pain
|
9.9%
8/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
Injection site haematoma
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
Pyrexia
|
32.1%
26/81 • Number of events 50 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
33.3%
13/39 • Number of events 27 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
General disorders
General physical health deterioration
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Psychiatric disorders
Anxiety
|
13.6%
11/81 • Number of events 12 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
10.3%
4/39 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Psychiatric disorders
Depression
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Psychiatric disorders
Confusional state
|
4.9%
4/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
0.00%
0/39 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Injury, poisoning and procedural complications
fall
|
12.3%
10/81 • Number of events 12 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
8.6%
7/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
2.5%
2/81 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Injury, poisoning and procedural complications
Food poisoning
|
0.00%
0/81 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood albumin decreased
|
29.6%
24/81 • Number of events 29 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Pancreatic enzymes abnormal
|
24.7%
20/81 • Number of events 31 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Transaminases increased
|
18.5%
15/81 • Number of events 40 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Antithrombin III decreased
|
21.0%
17/81 • Number of events 22 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
18.5%
15/81 • Number of events 18 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Weight decreased
|
9.9%
8/81 • Number of events 9 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
17.9%
7/39 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood Creatinine increased
|
14.8%
12/81 • Number of events 15 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood chloride increased
|
13.6%
11/81 • Number of events 15 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood urea increased
|
11.1%
9/81 • Number of events 9 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
10.3%
4/39 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.6%
7/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Vascular disorders
Purpura
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Vascular disorders
Haematoma
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Vascular disorders
Petechiae
|
3.7%
3/81 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Vascular disorders
Epistaxis
|
12.3%
10/81 • Number of events 12 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Vascular disorders
Hypertension
|
12.3%
10/81 • Number of events 12 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
10.3%
4/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Blood chloride decreased
|
6.2%
5/81 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Prothrombin time ratio decreased
|
9.9%
8/81 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
0.00%
0/39 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.4%
6/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
2/81 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Cardiac disorders
Cardiac failure
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
72.8%
59/81 • Number of events 149 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
82.1%
32/39 • Number of events 84 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.6%
41/81 • Number of events 87 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
48.7%
19/39 • Number of events 31 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.2%
35/81 • Number of events 98 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
46.2%
18/39 • Number of events 34 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.9%
8/81 • Number of events 9 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.9%
8/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.5%
2/81 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
76.5%
62/81 • Number of events 170 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
87.2%
34/39 • Number of events 74 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Hemorrhagic Events
|
25.9%
21/81 • Number of events 23 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
23.1%
9/39 • Number of events 11 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.6%
7/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.6%
11/81 • Number of events 14 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
20.5%
8/39 • Number of events 9 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
9/81 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
17.9%
7/39 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/81 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/81 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.7%
3/81 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Nervous system disorders
Headache
|
14.8%
12/81 • Number of events 13 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Ear and labyrinth disorders
Vertigo
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Nausea
|
29.6%
24/81 • Number of events 57 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
38.5%
15/39 • Number of events 21 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.6%
24/81 • Number of events 32 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
25.6%
10/39 • Number of events 12 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
18/81 • Number of events 22 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
25.6%
10/39 • Number of events 11 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Vomiting
|
17.3%
14/81 • Number of events 27 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 14 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Stomatitis
|
8.6%
7/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
11.1%
9/81 • Number of events 11 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
1/81 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
10.3%
4/39 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Odynophagia
|
1.2%
1/81 • Number of events 1 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/81 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
18.5%
15/81 • Number of events 25 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
2.6%
1/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Renal and urinary disorders
Renal failure
|
14.8%
12/81 • Number of events 13 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
12.8%
5/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.9%
8/81 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
4/81 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
5/81 • Number of events 7 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
10.3%
4/39 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
8/81 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
5/81 • Number of events 6 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
4/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
19.8%
16/81 • Number of events 19 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
23.1%
9/39 • Number of events 13 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
5/81 • Number of events 5 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
15.4%
6/39 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.9%
8/81 • Number of events 10 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
7.7%
3/39 • Number of events 4 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.9%
8/81 • Number of events 9 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.4%
6/81 • Number of events 8 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place