Trial Outcomes & Findings for A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) (NCT NCT04956666)
NCT ID: NCT04956666
Last Updated: 2023-12-29
Results Overview
All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Through study completion, approximately 19 months
Results posted on
2023-12-29
Participant Flow
Participant milestones
| Measure |
Lyophilized S95014
Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Lyophilized S95014
Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL.
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Baseline characteristics by cohort
| Measure |
Lyophilized S95014
n=74 Participants
Lyophilized S95014 reconstituted was provided 5 mL of extractable volume with the concentration of 750 U/mL.
|
|---|---|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 3.83 • n=5 Participants
|
|
Age, Customized
Age Category · < 10 years
|
60 Participants
n=5 Participants
|
|
Age, Customized
Age Category · [10, 15] years
|
12 Participants
n=5 Participants
|
|
Age, Customized
Age Category · ≥ 16 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status: 0
|
14 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status: 1
|
46 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status: 2
|
14 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
16.45 kg/m^2
STANDARD_DEVIATION 3.51 • n=5 Participants
|
|
Body Surface Area (m^2)
|
0.902 m^2
STANDARD_DEVIATION 0.356 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 19 monthsAll Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.
Outcome measures
| Measure |
Lyophilized S95014
n=74 Participants
Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL.
|
|---|---|
|
Incidence of Adverse Events (AEs) (Safety and Tolerability)
Number of Participants with an Adverse Event
|
74 Participants
|
|
Incidence of Adverse Events (AEs) (Safety and Tolerability)
Number of Participants with an Treatment Emergent Adverse Event
|
74 Participants
|
|
Incidence of Adverse Events (AEs) (Safety and Tolerability)
Number of Participants with a Grade 3 or 4 Treatment Emergent Adverse Event
|
72 Participants
|
|
Incidence of Adverse Events (AEs) (Safety and Tolerability)
Number of Participants with a Serious Treatment Emergent Adverse Event
|
27 Participants
|
Adverse Events
Lyophilized S95014
Serious events: 27 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lyophilized S95014
n=74 participants at risk
Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL.
|
|---|---|
|
Immune system disorders
Hypersensitivity
|
14.9%
11/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Immune system disorders
Anaphylactic reaction
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
COVID-19
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.7%
2/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Bronchitis
|
2.7%
2/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Sepsis
|
2.7%
2/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Neutropenic sepsis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Appendicitis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Cellulitis gangrenous
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Device related bacteraemia
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Device related infection
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Laryngitis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Pneumonia fungal
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.8%
5/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.4%
4/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Ejection fraction decreased
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Neutrophil count decreased
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
General disorders
General physical health deterioration
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
Other adverse events
| Measure |
Lyophilized S95014
n=74 participants at risk
Lyophilized S95014 reconstituted provided 5 mL of extractable volume with the concentration of 750 U/mL.
|
|---|---|
|
Investigations
Antithrombin III decreased
|
71.6%
53/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.2%
46/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Blood fibrinogen decreased
|
64.9%
48/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Alanine aminotransferase increased
|
47.3%
35/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
43.2%
32/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Gamma-glutamyltransferase increased
|
41.9%
31/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
32.4%
24/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Immune system disorders
Hypersensitivity
|
17.6%
13/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.0%
20/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.9%
14/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Protein S decreased
|
16.2%
12/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Blood bilirubin increased
|
14.9%
11/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Neutrophil count decreased
|
13.5%
10/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.9%
11/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
COVID-19
|
9.5%
7/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
White blood cell count decreased
|
10.8%
8/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.5%
7/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
General disorders
Pyrexia
|
9.5%
7/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Immune system disorders
Drug hypersensitivity
|
6.8%
5/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Lipase increased
|
8.1%
6/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.8%
5/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Nervous system disorders
Toxic neuropathy
|
6.8%
5/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Blood albumin decreased
|
5.4%
4/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Haemoglobin decreased
|
5.4%
4/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
5.4%
4/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
4/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Ammonia increased
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Amylase increased
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Lymphocyte count decreased
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Investigations
Platelet count decreased
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Rhinitis
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.1%
3/74 • Through study completion, approximately 19 months
Throughout the study multiple safety visits were conducted and patients underwent physical examinations, electrocardiograms, hematology, blood biochemistry, coagulation parameters, urinalysis, hepatitis serology, cardiac imaging, and vital sign measurements. During these assessments any abnormal values, test or exam results constituted an adverse event if they meet criteria or were deemed clinically significant by the investigator.
|
Additional Information
Clinical Studies Department
Institut de Recherches Internationales Servier (I.R.I.S.)
Phone: +33 1 55 72 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60