Trial Outcomes & Findings for Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia (NCT NCT01523782)

NCT ID: NCT01523782

Last Updated: 2021-10-15

Results Overview

The main evaluation criterion is a composite efficacy/toxicity criterion. Efficacy, assessed during induction 1: percentage of patients responding to treatment, i.e. with plasma Asn concentration ≤2µM (depleted), for a duration of at least 7 days after the administration of GRASPA®

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 7 days after the first administration of GRASPA® during Induction 1
• Results posted on: 2021-10-15

Participant Flow

Participant milestones

Measure	GRASPA 50 IU/kg Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Overall Study STARTED	3	13	14
Overall Study COMPLETED	2	13	9
Overall Study NOT COMPLETED	1	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	Total n=30 Participants Total of all reporting groups
Age, Continuous	68.33 years n=5 Participants	66.92 years n=7 Participants	67.00 years n=5 Participants	67.10 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment France	3 participants n=5 Participants	13 participants n=7 Participants	14 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 days after the first administration of GRASPA® during Induction 1

The main evaluation criterion is a composite efficacy/toxicity criterion. Efficacy, assessed during induction 1: percentage of patients responding to treatment, i.e. with plasma Asn concentration ≤2µM (depleted), for a duration of at least 7 days after the administration of GRASPA®

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment	0 Participants	11 Participants	10 Participants

PRIMARY outcome

Timeframe: Induction 1 and Induction 2

Safety: Toxicity, assessed during Induction 1 and Induction 2: according to NCI-CTCAE v3.0 August 2006, with Dose Limiting Toxicities (DLT) defined as: Grade 2 to 4 pancreatic toxicity, Grade 3 or 4 hepatic toxicity, allergic toxicity or deep cerebral thrombosis, known as potentially related to L-asparaginase; hematological toxicity defined as bone marrow blast free aplasia, 30 days following the last injection of chemotherapy, all other Grade 4 toxicities.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2	0 DLTs	5 DLTs	17 DLTs

SECONDARY outcome

Timeframe: Induction 1 & Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean plasma concentration of asparagine over time. Participants who were Below the Lower Limit of Quantification (BLLQ) were assigned a value of 0.51 μmol/L.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Plasma Concentrations of Asparagine Induction 1, Day 3	60.86 μmol/L Standard Deviation 9.38	46.74 μmol/L Standard Deviation 21.44	42.33 μmol/L Standard Deviation 10.98
Plasma Concentrations of Asparagine Induction 1, Day 4	0.51 μmol/L Standard Deviation 0	0.51 μmol/L Standard Deviation 0	0.51 μmol/L Standard Deviation 0
Plasma Concentrations of Asparagine Induction 1, Day 10	17.48 μmol/L Standard Deviation 11.46	1.78 μmol/L Standard Deviation 3.39	3.11 μmol/L Standard Deviation 4.05
Plasma Concentrations of Asparagine Induction 1, Day 17	16.33 μmol/L Standard Deviation 9.62	10.05 μmol/L Standard Deviation 8.10	9.30 μmol/L Standard Deviation 7.39
Plasma Concentrations of Asparagine Induction 1, Day 22-28	24.55 μmol/L Standard Deviation 1.60	20.35 μmol/L Standard Deviation 10.60	18.76 μmol/L Standard Deviation 8.74
Plasma Concentrations of Asparagine Induction 2, Day 6	45.39 μmol/L Standard Deviation 1.24	28.11 μmol/L Standard Deviation 9.74	27.16 μmol/L Standard Deviation 14.45
Plasma Concentrations of Asparagine Induction 2, Day 7	9.41 μmol/L Standard Deviation 12.59	9.44 μmol/L Standard Deviation 16.23	0.51 μmol/L Standard Deviation 0
Plasma Concentrations of Asparagine Induction 2, Day 13	29.47 μmol/L Standard Deviation 34.69	10.37 μmol/L Standard Deviation 11.16	3.79 μmol/L Standard Deviation 6.58
Plasma Concentrations of Asparagine Induction 2, Day 20	34.20 μmol/L Standard Deviation 8.48	13.71 μmol/L Standard Deviation 10.40	12.91 μmol/L Standard Deviation 8.17
Plasma Concentrations of Asparagine Induction 2, Day 22 to D28	46.22 μmol/L Standard Deviation 28.92	17.27 μmol/L Standard Deviation 12.12	17.23 μmol/L Standard Deviation 4.77

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean plasma concentration of aspartic acid over time.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Plasma Concentrations of Aspartic Acid Induction 1, D3	1.91 μmol/L Standard Deviation 0.28	2.38 μmol/L Standard Deviation 4.39	3.59 μmol/L Standard Deviation 5.03
Plasma Concentrations of Aspartic Acid Induction 1, D4	11.08 μmol/L Standard Deviation 4.14	5.22 μmol/L Standard Deviation 1.81	8.11 μmol/L Standard Deviation 5.50
Plasma Concentrations of Aspartic Acid Induction 1, D10	17.93 μmol/L Standard Deviation 3.65	16.47 μmol/L Standard Deviation 6.17	13.51 μmol/L Standard Deviation 5.16
Plasma Concentrations of Aspartic Acid Induction 1, D17	3.76 μmol/L Standard Deviation 1.39	10.60 μmol/L Standard Deviation 6.02	8.43 μmol/L Standard Deviation 4.58
Plasma Concentrations of Aspartic Acid Induction 1, D22-28	5.17 μmol/L Standard Deviation 1.82	10.27 μmol/L Standard Deviation 9.88	6.93 μmol/L Standard Deviation 5.31
Plasma Concentrations of Aspartic Acid Induction 2, D6	2.32 μmol/L Standard Deviation 0.63	4.17 μmol/L Standard Deviation 4.31	5.08 μmol/L Standard Deviation 3.35
Plasma Concentrations of Aspartic Acid Induction 2, D7	12.06 μmol/L Standard Deviation 6.36	6.35 μmol/L Standard Deviation 3.67	7.59 μmol/L Standard Deviation 3.45
Plasma Concentrations of Aspartic Acid Induction 2, D13	9.07 μmol/L Standard Deviation 8.92	9.82 μmol/L Standard Deviation 6.52	10.07 μmol/L Standard Deviation 5.19
Plasma Concentrations of Aspartic Acid Induction 2, D20	2.56 μmol/L Standard Deviation 0.37	8.39 μmol/L Standard Deviation 6.58	7.06 μmol/L Standard Deviation 5.28
Plasma Concentrations of Aspartic Acid Induction 2, D22-28	3.37 μmol/L Standard Deviation 1.00	11.04 μmol/L Standard Deviation 8.66	6.32 μmol/L Standard Deviation 4.75

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean glutamine concentration over time.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Plasma Concentrations of Glutamine Induction 1, D3	558.78 μmol/L Standard Deviation 158.02	484.19 μmol/L Standard Deviation 137.05	432.07 μmol/L Standard Deviation 69.93
Plasma Concentrations of Glutamine Induction 1, D4	616.13 μmol/L Standard Deviation 184.59	494.76 μmol/L Standard Deviation 142.95	463.03 μmol/L Standard Deviation 117.79
Plasma Concentrations of Glutamine Induction 1, D10	576.86 μmol/L Standard Deviation 172.51	521.86 μmol/L Standard Deviation 180.41	447.07 μmol/L Standard Deviation 159.93
Plasma Concentrations of Glutamine Induction 1, D17	384.12 μmol/L Standard Deviation 28.05	344.03 μmol/L Standard Deviation 102.95	266.08 μmol/L Standard Deviation 71.48
Plasma Concentrations of Glutamine Induction 1, D22-28	394.53 μmol/L Standard Deviation 21.50	422.76 μmol/L Standard Deviation 175.67	393.87 μmol/L Standard Deviation 78.01
Plasma Concentrations of Glutamine Induction 2, D6	508.99 μmol/L Standard Deviation 17.53	436.71 μmol/L Standard Deviation 140.02	426.28 μmol/L Standard Deviation 72.15
Plasma Concentrations of Glutamine Induction 2, D7	553.63 μmol/L Standard Deviation 71.15	498.41 μmol/L Standard Deviation 131.33	445.00 μmol/L Standard Deviation 145.95
Plasma Concentrations of Glutamine Induction 2, D13	517.42 μmol/L Standard Deviation 50.94	467.52 μmol/L Standard Deviation 136.17	456.52 μmol/L Standard Deviation 113.75
Plasma Concentrations of Glutamine Induction 2, D20	436.17 μmol/L Standard Deviation 15.72	406.62 μmol/L Standard Deviation 101.32	394.51 μmol/L Standard Deviation 69.15
Plasma Concentrations of Glutamine Induction 2, D22-28	530.40 μmol/L Standard Deviation 167.13	504.97 μmol/L Standard Deviation 117.83	441.50 μmol/L Standard Deviation 60.63

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean glutamic acid concentration over time.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Plasma Concentrations of Glutamic Acid. Induction 1, D3	49.96 μmol/L Standard Deviation 17.23	28.68 μmol/L Standard Deviation 18.01	39.87 μmol/L Standard Deviation 49.71
Plasma Concentrations of Glutamic Acid. Induction 1, D4	94.73 μmol/L Standard Deviation 35.53	54.38 μmol/L Standard Deviation 29.68	52.17 μmol/L Standard Deviation 29.01
Plasma Concentrations of Glutamic Acid. Induction 1, D10	53.58 μmol/L Standard Deviation 6.94	31.87 μmol/L Standard Deviation 17.41	31.82 μmol/L Standard Deviation 23.20
Plasma Concentrations of Glutamic Acid. Induction 1, D17	65.73 μmol/L Standard Deviation 21.31	39.71 μmol/L Standard Deviation 27.67	31.57 μmol/L Standard Deviation 23.33
Plasma Concentrations of Glutamic Acid. Induction 1, D22-28	42.83 μmol/L Standard Deviation 2.56	46.74 μmol/L Standard Deviation 27.49	36.49 μmol/L Standard Deviation 22.90
Plasma Concentrations of Glutamic Acid. Induction 2, D6	58.94 μmol/L Standard Deviation 37.41	53.88 μmol/L Standard Deviation 29.03	55.94 μmol/L Standard Deviation 32.51
Plasma Concentrations of Glutamic Acid. Induction 2, D7	77.11 μmol/L Standard Deviation 29.37	63.51 μmol/L Standard Deviation 35.37	83.98 μmol/L Standard Deviation 49.74
Plasma Concentrations of Glutamic Acid. Induction 2, D13	34.70 μmol/L Standard Deviation 9.57	53.64 μmol/L Standard Deviation 27.70	52.24 μmol/L Standard Deviation 23.91
Plasma Concentrations of Glutamic Acid. Induction 2, D20	27.83 μmol/L Standard Deviation 7.63	42.86 μmol/L Standard Deviation 20.70	35.09 μmol/L Standard Deviation 14.87
Plasma Concentrations of Glutamic Acid. Induction 2, D22-28	56.21 μmol/L Standard Deviation 1.85	47.92 μmol/L Standard Deviation 31.07	42.62 μmol/L Standard Deviation 11.94

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean cerebral spinal fluid asparagine concentration over time.

Outcome measures

Measure	GRASPA 50 IU/kg n=2 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=12 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=9 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Cerebral Spinal Fluid Concentrations of Asparagine Induction 1, D2	5.98 μmol/L Standard Deviation 0.63	8.35 μmol/L Standard Deviation 3.20	6.06 μmol/L Standard Deviation 3.17
Cerebral Spinal Fluid Concentrations of Asparagine Induction 1, D9	6.57 μmol/L Standard Deviation 2.72	1.47 μmol/L Standard Deviation 1.28	1.61 μmol/L Standard Deviation 1.09
Cerebral Spinal Fluid Concentrations of Asparagine Induction 2, D2	6.24 μmol/L Standard Deviation 1.07	6.42 μmol/L Standard Deviation 2.62	7.59 μmol/L Standard Deviation 5.58
Cerebral Spinal Fluid Concentrations of Asparagine Induction 2, D9	5.09 μmol/L Standard Deviation 2.99	2.74 μmol/L Standard Deviation 4.24	0.52 μmol/L Standard Deviation 0.03

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean cerebral spinal fluid aspartic acid concentration

Outcome measures

Measure	GRASPA 50 IU/kg n=2 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=12 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=9 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Cerebral Spinal Fluid Concentrations of Aspartic Acid Induction 1, D2	.95 μmol/L Standard Deviation 0.00	.95 μmol/L Standard Deviation 0.00	.95 μmol/L Standard Deviation 0.01
Cerebral Spinal Fluid Concentrations of Aspartic Acid Induction 1, D9	.95 μmol/L Standard Deviation 0.00	1.04 μmol/L Standard Deviation 0.32	1.10 μmol/L Standard Deviation 0.46
Cerebral Spinal Fluid Concentrations of Aspartic Acid Induction 2, D2	.95 μmol/L Standard Deviation 0.00	.95 μmol/L Standard Deviation 0.00	1.35 μmol/L Standard Deviation 0.98
Cerebral Spinal Fluid Concentrations of Aspartic Acid Induction 2, D9	.95 μmol/L Standard Deviation 0.00	1.09 μmol/L Standard Deviation 0.26	.95 μmol/L Standard Deviation 0.00

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean cerebral spinal fluid glutamine concentration

Outcome measures

Measure	GRASPA 50 IU/kg n=2 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=12 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=9 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Cerebral Spinal Fluid Concentrations of Glutamine Induction 1, D2	270.57 μmol/L Standard Deviation 108.21	441.34 μmol/L Standard Deviation 239.50	408.56 μmol/L Standard Deviation 116.84
Cerebral Spinal Fluid Concentrations of Glutamine Induction 1, D9	395.76 μmol/L Standard Deviation 32.50	363.40 μmol/L Standard Deviation 142.12	360.57 μmol/L Standard Deviation 99.56
Cerebral Spinal Fluid Concentrations of Glutamine Induction 2, D2	345.41 μmol/L Standard Deviation 4.13	358.90 μmol/L Standard Deviation 107.03	378.14 μmol/L Standard Deviation 70.19
Cerebral Spinal Fluid Concentrations of Glutamine Induction 2, D9	372.56 μmol/L Standard Deviation 15.67	420.96 μmol/L Standard Deviation 93.42	351.30 μmol/L Standard Deviation 44.86

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Mean cerebral spinal fluid glutamic acid concentration

Outcome measures

Measure	GRASPA 50 IU/kg n=2 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=12 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=9 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Cerebral Spinal Fluid Concentrations of Glutamic Acid Induction 1, D2	91.55 μmol/L Standard Deviation 39.44	91.98 μmol/L Standard Deviation 85.00	61.48 μmol/L Standard Deviation 53.96
Cerebral Spinal Fluid Concentrations of Glutamic Acid Induction 1, D9	132.53 μmol/L Standard Deviation 15.09	71.78 μmol/L Standard Deviation 38.44	43.93 μmol/L Standard Deviation 30.53
Cerebral Spinal Fluid Concentrations of Glutamic Acid Induction 2, D2	69.35 μmol/L Standard Deviation 5.70	52.89 μmol/L Standard Deviation 24.63	41.24 μmol/L Standard Deviation 20.18
Cerebral Spinal Fluid Concentrations of Glutamic Acid Induction 2, D9	62.04 μmol/L Standard Deviation 8.37	60.30 μmol/L Standard Deviation 28.32	47.02 μmol/L Standard Deviation 39.12

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Summary of Free Asparaginase Over Time Induction 1, D4	2.21 U/L Standard Deviation 0.57	6.87 U/L Standard Deviation 5.77	4.96 U/L Standard Deviation 2.63
Summary of Free Asparaginase Over Time Induction 1, D3	3.33 U/L Standard Deviation 0.00	3.38 U/L Standard Deviation 0.16	3.33 U/L Standard Deviation 0.00
Summary of Free Asparaginase Over Time Induction 1, D10	0.48 U/L Standard Deviation 0.09	0.53 U/L Standard Deviation 0.23	0.51 U/L Standard Deviation 0.30
Summary of Free Asparaginase Over Time Induction 1, D17	0.73 U/L Standard Deviation 0.38	0.34 U/L Standard Deviation 0.10	0.42 U/L Standard Deviation 0.26
Summary of Free Asparaginase Over Time Induction 1, D22-28	0.66 U/L Standard Deviation 0.11	0.59 U/L Standard Deviation 0.37	0.49 U/L Standard Deviation 0.32
Summary of Free Asparaginase Over Time Induction 2, D6	3.33 U/L Standard Deviation 0.00	1.19 U/L Standard Deviation 1.03	0.52 U/L Standard Deviation 0.18
Summary of Free Asparaginase Over Time Induction 2, D7	1.47 U/L Standard Deviation 1.65	3.50 U/L Standard Deviation 2.86	4.96 U/L Standard Deviation 3.78
Summary of Free Asparaginase Over Time Induction 2, D13	0.35 U/L Standard Deviation 0.02	0.52 U/L Standard Deviation 0.35	0.45 U/L Standard Deviation 0.38
Summary of Free Asparaginase Over Time Induction 2, D20	0.45 U/L Standard Deviation 0.04	0.46 U/L Standard Deviation 0.42	0.24 U/L Standard Deviation 0.07
Summary of Free Asparaginase Over Time Induction 2, D22-28	0.49 U/L Standard Deviation 0.00	0.68 U/L Standard Deviation 0.95	0.35 U/L Standard Deviation 0.10

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 1, D3	72.50 U/L Standard Deviation 0.00	239.49 U/L Standard Deviation 602.11	72.50 U/L Standard Deviation 0.00
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 1, D4	915.32 U/L Standard Deviation 137.09	1308.48 U/L Standard Deviation 490.99	1795.03 U/L Standard Deviation 564.74
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 1, D10	579.22 U/L Standard Deviation 129.99	1105.24 U/L Standard Deviation 339.77	1309.08 U/L Standard Deviation 497.53
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 1, D17	402.41 U/L Standard Deviation 181.91	790.39 U/L Standard Deviation 193.78	793.97 U/L Standard Deviation 291.67
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 1, D22-28	383.59 U/L Standard Deviation 62.77	571.49 U/L Standard Deviation 225.69	629.35 U/L Standard Deviation 253.60
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 2, D6	72.50 U/L Standard Deviation 0.00	382.51 U/L Standard Deviation 275.00	524.37 U/L Standard Deviation 164.72
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 2, D7	722.57 U/L Standard Deviation 120.11	1223.20 U/L Standard Deviation 323.83	1913.32 U/L Standard Deviation 788.45
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 2, D13	714.90 U/L Standard Deviation 49.91	1051.64 U/L Standard Deviation 285.32	1536.06 U/L Standard Deviation 401.09
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 2, D20	556.00 U/L Standard Deviation 52.10	745.22 U/L Standard Deviation 288.06	1191.24 U/L Standard Deviation 450.38
Summary of Encapsulated Asparaginase (U/L) Over Time Induction 2, D22-28	509.20 U/L Standard Deviation 0	673.64 U/L Standard Deviation 307.10	813.98 U/L Standard Deviation 240.88

SECONDARY outcome

Timeframe: Induction 1 and Induction 2

Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.

Evaluation of the number of patients testing positive for anti-asparaginase antibodies.

Outcome measures

Measure	GRASPA 50 IU/kg n=3 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Number of Patients Positive for Anti-L-asparaginase Antibodies Induction 1, D3	0 Participants	0 Participants	0 Participants
Number of Patients Positive for Anti-L-asparaginase Antibodies Induction 1, D4	0 Participants	0 Participants	0 Participants
Number of Patients Positive for Anti-L-asparaginase Antibodies Induction 1, D22-28	0 Participants	1 Participants	1 Participants
Number of Patients Positive for Anti-L-asparaginase Antibodies Induction 2, D6	0 Participants	0 Participants	1 Participants
Number of Patients Positive for Anti-L-asparaginase Antibodies Induction 2, D22-28	1 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 and 2 months

Population: 28 patients were analyzed for CR after Induction 1 (2 pts in 50 IU/kg; 13 pts in 100 IU/kg; 13 pts in 150 IU/kg). 22 patients were analyzed for CR after Induction 2 (2 pts in 50 IU/kg; 11 pts in 100 IU/kg; 9 pts in 150 IU/kg).

CR was defined using:

• Clinical criteria: disappearance of clinical signs of acute lymphocytic leukemia (ALL)
• Blood criteria: neutrophils > 1 G/L and platelets >100 G/L
• Medullary criteria: normally rich bone marrow and percentage of blasts <5%

Outcome measures

Measure	GRASPA 50 IU/kg n=2 Participants Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 Participants Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=13 Participants Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 Participants who met CR criteria at Induction 1	2 Participants	10 Participants	8 Participants
Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 Participants who met CR criteria at Induction 2	2 Participants	10 Participants	7 Participants

Adverse Events

GRASPA 50 IU/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

GRASPA 100 IU/kg

Serious events: 13 serious events

Other events: 13 other events

Deaths: 2 deaths

GRASPA 150 IU/kg

Serious events: 13 serious events

Other events: 14 other events

Deaths: 3 deaths

Serious adverse events

Measure	GRASPA 50 IU/kg n=3 participants at risk Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 participants at risk Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 participants at risk Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Infections and infestations Septic Shock	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	21.4% 3/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Escherichia sepsis	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Aspergillosis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Pneumonia herpes viral	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia recurrent	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	46.2% 6/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	35.7% 5/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Blood and lymphatic system disorders Febrile bone marrow aplasia	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Immune system disorders Drug hypersensitivity	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Antithrombin III decreased	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Pancreatic enzymes increased	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Cardiac disorders Arrythmia	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Hepatobiliary disorders Cytolytic hepatitis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Nervous system disorders Metabolic encephalopathy	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Renal and urinary disorders Renal failure	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Sepsis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Bacterial Sepsis	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Cellulitis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Citrobacter infection	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Diverticulitis	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Herpes zoster	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Klebsiella sepsis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Lung infection	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Pneumocystitis jroveci infection	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Pseudomonal sepsis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Staphylococcal sepsis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Stenotrophomonas sepsis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Vascular disorders Cerebrovascualr accident	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Vascular disorders Subarachnoid haemorrhage	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Vascular disorders Subclavian vein thrombosis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Vascular disorders Venous thrombosis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Gastrointestinal disorders Faecaloma	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Gastrointestinal disorders Haemmorhoids	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
General disorders Generalised oedema	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
General disorders Infusion site ulcer	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
General disorders Multi-organ failure	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Hypernatremia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").

Other adverse events

Measure	GRASPA 50 IU/kg n=3 participants at risk Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 100 IU/kg n=13 participants at risk Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase	GRASPA 150 IU/kg n=14 participants at risk Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase GRASPA: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Investigations Antithrombin III decreased	66.7% 2/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	53.8% 7/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	85.7% 12/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Gamma-glutamyltransferase increased	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	46.2% 6/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Alanine aminotransferase increased	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	30.8% 4/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Blood glucose increased	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	30.8% 4/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Blood bilirubin increased	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	46.2% 6/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Blood fibrinogen decreased	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Lipase increased	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	21.4% 3/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Prothrombin level decreased	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	35.7% 5/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Activated partial thromboplastin time prolonged	66.7% 2/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	21.4% 3/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Blood albumin decreased	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Pancreatic enzymes increased	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Investigations Aspartate aminotransferase increased	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Septic Shock	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	21.4% 3/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Aspergillosis	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Escherichia sepsis	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Lung infection	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Infections and infestations Oral herpes	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	57.1% 8/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Hypocalcaemia	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	21.4% 3/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	30.8% 4/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia recurrent	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	46.2% 6/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	35.7% 5/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Hepatobiliary disorders Cytolytic hepatitis	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Immune system disorders Drug hypersensitivity	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Gastrointestinal disorders Gastrointestinal disorders	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Respiratory, thoracic and mediastinal disorders Respiratory disorders	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	30.8% 4/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Renal and urinary disorders Renal failure acute	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.1% 1/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Renal and urinary disorders Renal failure	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	0.00% 0/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
General disorders General disorder	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Nervous system disorders Nervous system	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Blood and lymphatic system disorders Febrile bone marrow aplasia	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	23.1% 3/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	28.6% 4/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	7.7% 1/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	14.3% 2/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
Vascular disorders Vascular disorder	33.3% 1/3 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	15.4% 2/13 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").	35.7% 5/14 • The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12). Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").

Additional Information

Denise Tilton, Global Head Clinical Operations & Program Management

ERYTECH Pharma

Phone: +1 857-706-1587

Email: dtilton@erytech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60