Trial Outcomes & Findings for Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer (NCT NCT01523808)

Last Updated: 2021-10-15

Results Overview

Dose limiting toxicities were defined according to CTCAE v3.0 as follow: Known toxicities related to asparaginase: * Pancreatic grade 2, 3 or 4 * Allergic, Neurological, Hepatic, Coagulation grade 3 or 4 an any other toxicity of grade 4

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-10-15

Participant Flow

Participants were recruited at 3 investigational sites in France between November 2009 and February 2011. The first participant was enrolled in the study on 27 November 2009 and the last patient exited the study on 30 March 2011.

This was not a randomized study. No washout or run-in was required. Assignment of patients to treatment groups followed study design rules, per protocol.

Participant milestones

Participant milestones
Measure	GRASPA 25 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose	GRASPA 50 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose	GRASPA 100 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose	GRASPA 150 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
Overall Study STARTED	3	3	3	3
Overall Study COMPLETED	0	3	1	0
Overall Study NOT COMPLETED	3	0	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GRASPA 25 n=3 Participants Participants received one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Age, Continuous	56 years n=5 Participants	67 years n=7 Participants	51 years n=5 Participants	68 years n=4 Participants	60 years n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment France	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	GRASPA 25 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: AEs that met the following criteria were considered for the primary safety criterion: 1. Grade 2 to 4 of pancreatic toxicity - no symptomatic pancreatitis occurred for any patients 2. Grade 3 or 4 of hepatic toxicity - Two patients had antithrombin III decrease, but both cases were Grade 1; no cytolytic hepatitis 3. Other grade 4 toxicities

Limiting toxicities were defined according to CTCAE v3.0 as follow: Known toxicities related to asparaginase: * Pancreatic grade 2, 3 or 4 * Allergic, Neurological, Hepatic, Coagulation grade 3 or 4 Any other toxicity of grade 4

Outcome measures

Outcome measures
Measure	GRASPA 25 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56

Population: Data were available for dose levels (no. of patients) of 25 IU/kg (n=1), 50 IU/kg (n=0), 100 IU/kg (n=0), and 150 IU/kg (n=3).

Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase.

Outcome measures

Outcome measures
Measure	GRASPA 25 n=1 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life	19.34 days	22.71 days Standard Deviation 10.48	—	—

SECONDARY outcome

Timeframe: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56

Population: Data were available for dose levels (no. of patients) of 25 IU/kg (n=1), 50 IU/kg (n=0), 100 IU/kg (n=0), and 150 IU/kg (n=3).

Outcome measures

Outcome measures
Measure	GRASPA 25 n=1 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax	255.33 IU/L	1812.57 IU/L Standard Deviation 203.12	—	—

SECONDARY outcome

Timeframe: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56

Population: Data were available for dose levels (no. of patients) of 25 IU/kg (n=1), 50 IU/kg (n=0), 100 IU/kg (n=0), and 150 IU/kg (n=3).

Outcome measures

Outcome measures
Measure	GRASPA 25 n=1 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity	189363.84 hr*IU/L	1331430.20 hr*IU/L Standard Deviation 258279.50	—	—

SECONDARY outcome

Timeframe: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56

Population: 12 patients were included and analyzed corresponding to 1 cohort of 3 patients per dose. Data shown is a summary of the relative change of asparagine (%) from baseline over time (analysis set)

Duration of plasma asparagine depletion (less than or equal to 2 micromoles/Liter or deamination greater than 90% compared to baseline levels and serum concentrations of L-asparagine, L-aspartate, L-glutamine, and L-glutamate. For pharmacodynamic data, the administration date of the investigational treatment was considered as the reference date for duration calculation. All patients having received a single dose of studied drug GRASPA have been analyzed.

Outcome measures

Outcome measures
Measure	GRASPA 25 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 7	-37.65 UI/Kg Standard Deviation 55.53	-80.06 UI/Kg Standard Deviation 15.68	-49.97 UI/Kg Standard Deviation 52.19	-93.02 UI/Kg Standard Deviation 7.35
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 0	0.00 UI/Kg Standard Deviation 0.00	0.00 UI/Kg Standard Deviation 0.00	0.00 UI/Kg Standard Deviation 0.00	0.00 UI/Kg Standard Deviation 0.00
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 1	-98.10 UI/Kg Standard Deviation 0.35	-98.36 UI/Kg Standard Deviation 0.60	-80.22 UI/Kg Standard Deviation 31.67	-97.26 UI/Kg Standard Deviation 0.02
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 3	-98.10 UI/Kg Standard Deviation 0.35	-91.39 UI/Kg Standard Deviation 11.49	-72.66 UI/Kg Standard Deviation 44.77	-97.36 UI/Kg Standard Deviation 0.18
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 14	3.74 UI/Kg Standard Deviation 33.84	-30.13 UI/Kg Standard Deviation 11.06	-6.63 UI/Kg Standard Deviation 8.46	-65.91 UI/Kg Standard Deviation 54.30
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 21	1.46 UI/Kg Standard Deviation 52.13	-13.21 UI/Kg Standard Deviation 41.76	-12.93 UI/Kg Standard Deviation 9.87	-31.64 UI/Kg Standard Deviation 41.65
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 28	8.77 UI/Kg Standard Deviation 63.51	-16.24 UI/Kg Standard Deviation 40.46	0.94 UI/Kg Standard Deviation 2.65	-6.55 UI/Kg Standard Deviation 8.54
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 35	-15.61 UI/Kg Standard Deviation 33.87	-10.95 UI/Kg Standard Deviation 18.03	7.50 UI/Kg	43.08 UI/Kg
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 42	—	-22.04 UI/Kg Standard Deviation 47.31	-7.81 UI/Kg	-1.82 UI/Kg
Change of Asparagine Levels From Baseline (Pharmacodynamics) Day 56	—	-74.80 UI/Kg	-7.26 UI/Kg	—

SECONDARY outcome

Timeframe: Day 0, 1, 28 and 56

Population: Summary of anti-L-asparaginase antibodies over time by number of patients

Titers of E. coli anti-asparaginase antibodies evaluated over time to assess immunogenicity

Outcome measures

Outcome measures
Measure	GRASPA 25 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Number of Patient Positive for Anti-L-asparaginase Antibodies Day 0	0 Participants	0 Participants	1 Participants	0 Participants
Number of Patient Positive for Anti-L-asparaginase Antibodies Day 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patient Positive for Anti-L-asparaginase Antibodies Day 28	2 Participants	3 Participants	3 Participants	0 Participants
Number of Patient Positive for Anti-L-asparaginase Antibodies Day 56	—	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 0, 28, 56

Population: Sample collection not completed at each timepoint for each patient. All data available presented below.

Assess tumor response, evaluated by carcinoembryonic antigen (CEA) tumor marker evolution

Outcome measures

Outcome measures
Measure	GRASPA 25 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Summary of CEA Level Over Time Day 28	22.8 ng/ml Interval 7.5 to 38.0	26.3 ng/ml Interval 7.5 to 30.9	3.1 ng/ml Interval 3.0 to 3.1	967.9 ng/ml Interval 14.2 to 995.4
Summary of CEA Level Over Time Day 0	21.3 ng/ml Interval 13.5 to 29.0	10.2 ng/ml Interval 10.0 to 19.0	6.4 ng/ml Interval 3.0 to 9.7	354.8 ng/ml Interval 12.5 to 488.2
Summary of CEA Level Over Time Day 56	—	9.0 ng/ml Interval 9.0 to 9.0	3.4 ng/ml Interval 3.4 to 3.4	—

SECONDARY outcome

Timeframe: Day 0, 28 and 56

Population: Sample collection not completed at each timepoint for each patient. All data available presented below.

Tumor response Evaluation by cancer antigen (CA)19.9 evolution over time

Outcome measures

Outcome measures
Measure	GRASPA 25 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 Participants GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Summary of CA 19.9 Over Time Day 0	18440.0 u/ml Interval 5605.0 to 36802.0	184.3 u/ml Interval 59.8 to 4751.0	1625.0 u/ml Interval 73.2 to 2835.0	54.5 u/ml Interval 3.5 to 1784.0
Summary of CA 19.9 Over Time Day 28	37196.5 u/ml Interval 14310.0 to 60083.0	748.3 u/ml Interval 187.2 to 12375.0	3136.0 u/ml Interval 122.0 to 6150.0	124.1 u/ml Interval 5.3 to 2395.0
Summary of CA 19.9 Over Time Day 56	—	561.8 u/ml Interval 561.8 to 561.8	195.5 u/ml Interval 195.5 to 195.5	—

Adverse Events

GRASPA 25

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

GRASPA 50

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GRASPA 100

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

GRASPA 150

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	GRASPA 25 n=3 participants at risk GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed	GRASPA 50 n=3 participants at risk GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 3 subjects completed	GRASPA 100 n=3 participants at risk GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 1 subject completed	GRASPA 150 n=3 participants at risk GRASPA: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose 3 subjects enrolled; 0 subjects completed
Respiratory, thoracic and mediastinal disorders Dyspnea related to pleural effusion	33.3% 1/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.
Musculoskeletal and connective tissue disorders Increase of Lumbar Pain	33.3% 1/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.
Gastrointestinal disorders Increase of Abdominal Pain	33.3% 1/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.	0.00% 0/3 • Reported Adverse Events (AEs) include events starting from patient inclusion until 2 month after GRASPA administration (~2.5 months) Adverse events regardless of grade or causality are reported. Events are summarized by system organ class and footnote indicates the specific events reported for each class.

Other adverse events

Additional Information

Director of Clinical Trials

Erytech Pharmaceuticals

Phone: +33 4 78 74 44 38

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place