BAX 855 Continuation

A Phase 3b Continuation Study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients With Severe Hemophilia A

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01945593

Enrollment

218

Registered

2013-09-18

Start date

2013-10-15

Completion date

2018-03-02

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Brief summary

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

Interventions

BIOLOGICALBAX855

Antihemophilic Factor (Recombinant), PEGylated

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

Healthy volunteers

Inclusion criteria

Participants Transitioning from Other BAX 855 Studies: Participants transitioning from other BAX 855 studies can be provided with the continuation study informed consent form (ICF) prior to the end of study visit to review and consider participation in this continuation study. These participants will complete any additional screening assessments within 2 weeks of the previous study's end of study visit and will return to the study site within 6 (± 1) weeks of the previous study end of study visit to confirm eligibility for this continuation study. * Participants transitioning from other BAX 855 studies who meet ALL of the following criteria are eligible for this study: 1. Participant has completed a previous BAX 855 study and is willing to immediately transition into this continuation study. 2. Participant is ≤75 years of age at screening of the previous BAX 855 study. 3. Participant continues to have a Karnofsky (for participants aged ≥ 16 years) or Lansky (for participants aged \< 16 years) performance score of ≥ 60. 4. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3, as confirmed by central laboratory at screening. 5. Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis. 6. If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study. 7. Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol. * BAX 855 Naïve Participants: BAX 855 naïve participants who are ≥ 12 years of age can only be enrolled in this continuation study after enrollment in the phase 2/3 pivotal study is closed. BAX 855 naïve participants who are \< 12 years of age can only be enrolled in this continuation study after enrollment in the pediatric previously treated patient (PTP) study is closed. \- Enrolment of BAX 855 naïve participants will only start once the sponsor has notified the study sites accordingly. BAX 855 naïve participants who meet ALL of the following criteria are eligible for this study: 1. Participant is ≤75 years of age at screening. 2. Participant is naïve to BAX 855. 3. Participant has severe hemophilia A (FVIII clotting activity \< 1%) as confirmed by central laboratory at screening after at least a 72-hour washout period. 4. Participant aged ≥ 6 years has documented previous treatment with plasma-derived FVIII or rFVIII for ≥ 150 exposure days (EDs). 5. Participant aged \< 6 years has documented previous treatment with plasma-derived FVIII concentrates or rFVIII for ≥ 50 EDs. 6. Participant is currently receiving prophylaxis or on-demand therapy with FVIII. 7. Participant has a Karnofsky (for participants aged ≥ 16 years) or Lansky (for participants aged \< 16 years) performance score of ≥ 60. 8. Participant is HIV-; or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3, as confirmed by central laboratory at screening. 9. Participant is HCV- by antibody or PCR testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis. 10. If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study. 11. Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol. EXCLUSION CRITERA \- Participants Transitioning from Other BAX 855 Studies: Participants transitioning from other BAX 855 studies who meet ANY of the following criteria are not eligible for this study: 1. Participant had detectable factor VIII (FVIII) inhibitory antibodies (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening. 2. Participant has developed FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay as determined at central laboratory in a previous BAX 855 study). 3. Participant has acquired a hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease) in a previous BAX 855 study. 4. Participant has severe chronic hepatic dysfunction (eg, ≥ 5 times upper limit of normal alanine aminotransferase \[ALT\], as confirmed by central laboratory at screening). 5. Participant has severe renal impairment (serum creatinine \> 2.0 mg/dL), as confirmed by central laboratory at screening. 6. Participant experienced a life-threatening or gastrointestinal bleeding episode within 3 months prior to study entry. 7. Participant is scheduled to use other PEGylated drugs during study participation. 8. Participant is planning to take part in any other clinical study during the course of the continuation study, with the exception of any other parallel BAX 855 study. 9. Participant has medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. 10. Participant is a family member or employee of the investigator. * BAX 855 Naïve Participants: BAX 855 naïve participants who meet ANY of the following criteria are not eligible for this study: 1. Participant has detectable FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening. 2. Participant has history of FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay or the Bethesda assay) at any time prior to screening. 3. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease). 4. Participant has known hypersensitivity towards mouse or hamster proteins, polyethylene glycol (PEG), or Tween 80. 5. Participant has severe chronic hepatic dysfunction eg, ≥ 5 times upper limit of normal ALT, as confirmed by central laboratory at screening). 6. Participant has severe renal impairment (serum creatinine \> 2.0 mg/dL), as confirmed by central laboratory at screening. 7. Participant experienced a life-threatening or gastrointestinal bleeding episode within 3 months prior to study entry. 8. Participant has current or recent (\< 30 days) use of other PEGylated drugs prior to study participation or scheduled use of such drugs during study participation. 9. Participant has participated in another clinical study involving an IP other than BAX 855 or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device during the course of this study. 10. Participant has medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. 11. Participant is a family member or employee of the investigator.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)	Baseline through end of study (53 months)	Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.
Annualized Bleed Rate (ABR) - Spontaneous Bleeds	Baseline through end of study (53 months)	The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The ABR of spontaneous bleeds was reported separately for twice weekly, PK-t R, each of the every 5 days and every 7 days treatment regimens at the time of bleed.

Secondary

Measure	Time frame	Description
BAX 855 Infusions Needed to Treat Bleeding Episodes	Baseline through end of study (53 months)	The BAX 855 infusions to treat each bleeding episode was determined by the participant, the participant's caregiver, and/or investigator, and was based upon the participant's response to treatment. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.
Total Time Intervals Between Bleeding Episodes	Baseline through end of study (53 months)	The time interval between bleeding episodes was calculated based upon the date and time reported for each bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.
Average Dose of BAX 855 Per Prophylactic Infusion	Baseline through end of study (53 months)	The average dose of BAX 855 per prophylactic infusion was reported.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline through end of study (53 months)	An AE was any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an investigational product (IP), whether or not considered causally related to the IP. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death; was life-threatening; required inpatient hospitalization or resulted in prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a medically important event.
Change From Baseline in Body Temperature	Baseline, end of study (53 months)	Change in body temperature at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.
Change From Baseline in Pulse Rate	Baseline, end of study (53 months)	Change in pulse rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.
Change From Baseline in Respiratory Rate	Baseline, end of study (53 months)	Change in respiratory rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.
Change From Baseline in Blood Pressure	Baseline, end of study (53 months)	Change in systolic and diastolic blood pressure at pre-infusion and post-infusion at end of the study were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, SBP refers to systolic blood pressure, DBP refers to diastolic blood pressure.
Total Annualized Bleed Rate (ABR)	Baseline through end of study (53 months)	The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. Bleeding occurring at multiple locations related to the same injury (e.g., knee and ankle bleed following a fall) was counted as a single bleeding episode. Total annualized bleed rate (spontaneous and traumatic bleeding episodes) was reported.
Number of Participants With Shifts in Hematology Laboratory Assessments	Baseline through end of study (53 months)	The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, Leu refers to leukocytes, MCV refers to mean corpuscular volume, Lym/Leu refers to lymphocytes/leukocytes.
Number of Participants With Shifts in Lipid Panel Assessments	Baseline through end of study (53 months)	The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported.. In the below table, HDL refers to high density lipoprotein, LDL refers to low density lipoprotein, VLDL refers to very low density lipoprotein.
Number of Participants With Binding Antibodies	Baseline through end of study (53 months)	Binding antibodies (IgG and IgM) against FVIII, polyethylene glycol (PEG) and PEGylated FVIII (PEG-FVIII) were analyzed using enzyme-linked immunosorbent assay (ELISA).
Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies	Baseline through end of study (53 months)	Testing for binding of anti-CHO protein antibodies was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal antihuman IgG antibodies.
Change From Baseline in Bleed Severity	Baseline, end of study (53 months)	Hemophilia symptom (haemo-SYM) questionnaire has two subscales: pain and bleed. It was used to asses the bleed severity for participants \>=18 years of age as: severity of spontaneous bleeding in my joints (unrelated to injury or activity), spontaneous bleeding in my muscles (unrelated to injury or activity), prolonged bleeding after injury in spite of treatment, intense pain because of bleeding event, joint pain due to active bleed and bleeding during personal hygiene routine, blood in my urine, nose bleeds and assigned a score of 0=Absent, 1=very mild, 2=mild, 3=moderate, 4=severe and 5=very severe. The score was determined as (mean score/5)\*100 where mean score is the mean of the available results in the particular subscale. Higher scores on the Haemo-SYM indicate more severe symptoms. Therefore, negative change scores indicate that symptoms have improved. Here 'n' refers to the number of participants evaluable for this endpoint.
Change From Baseline in Pain Severity	Baseline, end of study (53 months)	Hemophilia symptom (haemo-SYM) questionnaire has two subscales: pain and bleed. It was used to asses the pain severity for participants \>=18 years of age as: pain because of swelling in my joints, climbing stairs, upon waking in the morning, active arthritis; constant pain, in my muscles, that needs medication; joint sensitivity to weather conditions; reduced range of joint movement, joint deformity, sleep disturbance because of pain or bleeds, blood in my urine, nose bleeds and assigned a score of 0=Absent, 1=very mild, 2=mild, 3=moderate, 4=severe and 5=very severe. The score was determined as (mean score/5)\*100 where mean score is the mean of the available results in the particular subscale. Higher scores on the Haemo-SYM indicate more severe symptoms. Therefore, negative change scores indicate that symptoms have improved. Here 'n' refers to the number of participants evaluable for this endpoint.
Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	Baseline, end of study (53 months)	HRQoL in participants aged \>=14 years was measured using the SF-36 questionnaire. The questionnaire was divided into 8 domains and scored as: physical functioning (1=yes, limited a lot to 3=no, not limited at all), role-physical (1=all of the time to 5=none of the time), bodily pain (1=very severe to 6=none), general health (1=poor to 5=excellent), vitality (1=none of the time to 5=all of the time), social functioning (1=all of the time: to 5=none of the time), role emotional (1=all of the time to 5=none of the time) and mental health (1=all of the time to 5=none of the time). The score for each domain is then to be transformed to a 0-100 range as \[(actual raw score-lowest possible raw score)/possible raw score range\]\*100. Positive change scores indicate improved HRQoL. in the below table 'FDR' indicates fixed dose regimen, 'PK-tr' indicates pharmacokinetically tailored regimen and 'n' refers to the number of participants evaluable for this endpoint.
Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	Baseline, end of study (53 months)	HRQoL in participants aged \<14 years was measured using the PedsQL. It capture data for the following domains: physical functioning, emotional functioning, social functioning, school functioning, psychosocial functioning, physical health and a total score. Each question of the PedsQL was scored as Never: 100, almost never: 75, sometimes: 50, often: 25, almost always: 0. The mean of the individual question scores was calculated. Lower scores on the PedsQL indicating worse HRQoL. Here, FDR refers to fixed dose regimen, PK-t R refers to PK-tailored regimen. Here 'n' refers to the number of participants evaluable for this endpoint. Here 'n' refers to the number of participants evaluable for this endpoint.
Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Baseline through end of study (53 months)	The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported. In the below table, FDR refers to fixed dose regimen at the time of sampling, AlA refers to alanine aminotransferase, AP refers to alkaline phosphatase, AsA refers to aspartate aminotransferase.
Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Baseline through end of study (53 months)	The participant or caregiver rated the overall treatment response at 24 (+/- 2) hours after the initiation of treatment using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens.

Countries

Australia, Austria, Bulgaria, Czechia, Germany, Hong Kong, Israel, Japan, Lithuania, Malaysia, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted at 86 centers in 23 countries between 15 October 2013 (first participant first visit) and 02 March 2018 (last participant last visit).

Pre-assignment details

A total of 218 subjects were enrolled, of them 216 subjects received treatment.

Participants by arm

Arm	Count
BAX 855: Age < 2 Years Participants of age \< 2 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of \>= 3% until at least 100 EDs were reached.	3
BAX 855: Age >= 2 to <12 Years Participants of age \>= 2 to \<12 years received an infusion of 50 +/- 10 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of \>= 3% until at least 100 EDs were reached.	62
BAX 855: Age >= 12 to <17 Years Participants of age \>= 12 to \<17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of \>= 3% until at least 100 EDs were reached.	26
BAX 855: Age >= 17 Years Participants of age \>= 17 years received an infusion of 45 +/- 5 IU/kg of BAX 855 twice weekly; could be increased to 80 IU/kg or a PK-tailored prophylactic dose (should not exceed 80 IU/kg and the FVIII peak level was not to exceed 200%) at least twice weekly based on the participant's individual PK to maintain FVIII trough levels of \>= 3% until at least 100 EDs were reached.	125
Total	216

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003
Overall Study	Adverse Event	0	0	5
Overall Study	Death	0	1	0
Overall Study	Other: Screen Failure	2	0	0
Overall Study	Other: Surgical Procedure	2	0	6
Overall Study	Other: Terminated	0	0	1
Overall Study	Physician Decision	0	1	1
Overall Study	Protocol Violation	2	1	3
Overall Study	Withdrawal by Subject	2	0	4

Baseline characteristics

Characteristic	Total	BAX 855: Age < 2 Years	BAX 855: Age >= 2 to <12 Years	BAX 855: Age >= 12 to <17 Years	BAX 855: Age >= 17 Years
Age, Continuous	22.8 Years STANDARD_DEVIATION 15.67	1.0 Years STANDARD_DEVIATION 0	6.0 Years STANDARD_DEVIATION 2.47	13.8 Years STANDARD_DEVIATION 1.3	33.5 Years STANDARD_DEVIATION 11.68
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	0 Participants	3 Participants	0 Participants	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	206 Participants	3 Participants	59 Participants	26 Participants	118 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	58 Participants	1 Participants	15 Participants	5 Participants	37 Participants
Race (NIH/OMB) Black or African American	4 Participants	0 Participants	3 Participants	1 Participants	0 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	152 Participants	2 Participants	42 Participants	20 Participants	88 Participants
Sex: Female, Male Female	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Sex: Female, Male Male	215 Participants	3 Participants	61 Participants	26 Participants	125 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 62	1 / 26	0 / 125
other Total, other adverse events	3 / 3	40 / 62	12 / 26	62 / 125
serious Total, serious adverse events	0 / 3	7 / 62	4 / 26	22 / 125

Outcome results

Primary

Annualized Bleed Rate (ABR) - Spontaneous Bleeds

The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The ABR of spontaneous bleeds was reported separately for twice weekly, PK-t R, each of the every 5 days and every 7 days treatment regimens at the time of bleed.

Time frame: Baseline through end of study (53 months)

Population: Full analysis set (FAS) included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Group	Value (MEDIAN)
BAX 855: Age < 2 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	FDR: Twice Weekly	0.614 Bleeds per year
BAX 855: Age >= 2 to <12 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	FDR: Twice Weekly	0.792 Bleeds per year
BAX 855: Age >= 2 to <12 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	PK-tailored regimen (PK-t R)	1.078 Bleeds per year
BAX 855: Age >= 12 to <17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	FDR: Twice Weekly	1.439 Bleeds per year
BAX 855: Age >= 12 to <17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	PK-tailored regimen (PK-t R)	1.602 Bleeds per year
BAX 855: Age >= 12 to <17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	FDR: Every 7 Days	0.669 Bleeds per year
BAX 855: Age >= 12 to <17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	Fixed-dose regimen (FDR): Every 5 Days	1.381 Bleeds per year
BAX 855: Age >= 17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	FDR: Twice Weekly	1.293 Bleeds per year
BAX 855: Age >= 17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	FDR: Every 7 Days	1.992 Bleeds per year
BAX 855: Age >= 17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	PK-tailored regimen (PK-t R)	0.868 Bleeds per year
BAX 855: Age >= 17 Years	Annualized Bleed Rate (ABR) - Spontaneous Bleeds	Fixed-dose regimen (FDR): Every 5 Days	1.160 Bleeds per year

Primary

Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)

Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.

Time frame: Baseline through end of study (53 months)

Population: Safety analysis set (SAS) included all participants with at least 1 BAX 855 infusion. The analysis included participants that developed inhibitory antibodies (IA) to FVIII and participants that did not develop IA to FVIII and had 100 or more exposure days (ED) to BAX 855 across all studies and a FVIII inhibitory test result after the 100th ED.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)	0 Participants

Secondary

Average Dose of BAX 855 Per Prophylactic Infusion

The average dose of BAX 855 per prophylactic infusion was reported.

Time frame: Baseline through end of study (53 months)

Population: SAS included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Average Dose of BAX 855 Per Prophylactic Infusion	50.748 International units per kilogram (IU/kg)	Standard Deviation 11.312
BAX 855: Age >= 2 to <12 Years	Average Dose of BAX 855 Per Prophylactic Infusion	53.855 International units per kilogram (IU/kg)	Standard Deviation 7.754
BAX 855: Age >= 12 to <17 Years	Average Dose of BAX 855 Per Prophylactic Infusion	53.356 International units per kilogram (IU/kg)	Standard Deviation 10.344
BAX 855: Age >= 17 Years	Average Dose of BAX 855 Per Prophylactic Infusion	49.727 International units per kilogram (IU/kg)	Standard Deviation 8.677

Secondary

BAX 855 Infusions Needed to Treat Bleeding Episodes

The BAX 855 infusions to treat each bleeding episode was determined by the participant, the participant's caregiver, and/or investigator, and was based upon the participant's response to treatment. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.

Time frame: Baseline through end of study (53 months)

Population: FAS included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	BAX 855 Infusions Needed to Treat Bleeding Episodes	1.3 Infusions	Standard Deviation 0.52
BAX 855: Age >= 2 to <12 Years	BAX 855 Infusions Needed to Treat Bleeding Episodes	1.4 Infusions	Standard Deviation 1.14
BAX 855: Age >= 12 to <17 Years	BAX 855 Infusions Needed to Treat Bleeding Episodes	1.4 Infusions	Standard Deviation 1.81
BAX 855: Age >= 17 Years	BAX 855 Infusions Needed to Treat Bleeding Episodes	1.4 Infusions	Standard Deviation 1.1

Secondary

Change From Baseline in Bleed Severity

Hemophilia symptom (haemo-SYM) questionnaire has two subscales: pain and bleed. It was used to asses the bleed severity for participants \>=18 years of age as: severity of spontaneous bleeding in my joints (unrelated to injury or activity), spontaneous bleeding in my muscles (unrelated to injury or activity), prolonged bleeding after injury in spite of treatment, intense pain because of bleeding event, joint pain due to active bleed and bleeding during personal hygiene routine, blood in my urine, nose bleeds and assigned a score of 0=Absent, 1=very mild, 2=mild, 3=moderate, 4=severe and 5=very severe. The score was determined as (mean score/5)\*100 where mean score is the mean of the available results in the particular subscale. Higher scores on the Haemo-SYM indicate more severe symptoms. Therefore, negative change scores indicate that symptoms have improved. Here 'n' refers to the number of participants evaluable for this endpoint.

Time frame: Baseline, end of study (53 months)

Population: FAS with population of age greater than or equal to 18 years were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Bleed Severity	Fixed dose regimen	-7.824 Score on a scale	Standard Deviation 18.514
BAX 855: Age < 2 Years	Change From Baseline in Bleed Severity	PK-tailored regimen	-16.667 Score on a scale	Standard Deviation 14.337

Secondary

Change From Baseline in Blood Pressure

Change in systolic and diastolic blood pressure at pre-infusion and post-infusion at end of the study were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, SBP refers to systolic blood pressure, DBP refers to diastolic blood pressure.

Time frame: Baseline, end of study (53 months)

Population: SAS with evaluable participants for this endpoint were analyzed. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Blood Pressure	DBP - FDR: Post-Infusion	5.3 Millimeter of mercury (mmHg)	Standard Deviation 8.74
BAX 855: Age < 2 Years	Change From Baseline in Blood Pressure	SBP - FDR: Post-Infusion	-8.7 Millimeter of mercury (mmHg)	Standard Deviation 8.5
BAX 855: Age < 2 Years	Change From Baseline in Blood Pressure	DBP - FDR: Pre-Infusion	0.7 Millimeter of mercury (mmHg)	Standard Deviation 8.02
BAX 855: Age < 2 Years	Change From Baseline in Blood Pressure	SBP - FDR: Pre-Infusion	-2.7 Millimeter of mercury (mmHg)	Standard Deviation 1.53
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	SBP - FDR: Post-Infusion	3 Millimeter of mercury (mmHg)	Standard Deviation 11.49
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	SBP - FDR: Pre-Infusion	4.5 Millimeter of mercury (mmHg)	Standard Deviation 11.82
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	SBP - PK-tR: Post-Infusion	-1.8 Millimeter of mercury (mmHg)	Standard Deviation 8.61
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	DBP - FDR: Post-Infusion	3 Millimeter of mercury (mmHg)	Standard Deviation 9.72
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	DBP - PK-tR: Pre-Infusion	2.3 Millimeter of mercury (mmHg)	Standard Deviation 9.65
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	DBP - PK-tR: Post-Infusion	-2.4 Millimeter of mercury (mmHg)	Standard Deviation 6.67
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	DBP - FDR: Pre-Infusion	1.8 Millimeter of mercury (mmHg)	Standard Deviation 9.73
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Blood Pressure	SBP - PK-tR: Pre-Infusion	0.9 Millimeter of mercury (mmHg)	Standard Deviation 8.04
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	DBP - PK-tR: Post-Infusion	-2.3 Millimeter of mercury (mmHg)	Standard Deviation 7.68
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	DBP - FDR: Pre-Infusion	1.4 Millimeter of mercury (mmHg)	Standard Deviation 9.69
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	DBP - FDR: Post-Infusion	0.3 Millimeter of mercury (mmHg)	Standard Deviation 6.43
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	DBP - PK-tR: Pre-Infusion	0.5 Millimeter of mercury (mmHg)	Standard Deviation 10.28
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	SBP - FDR: Pre-Infusion	4.0 Millimeter of mercury (mmHg)	Standard Deviation 9.25
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	SBP - FDR: Post-Infusion	2.7 Millimeter of mercury (mmHg)	Standard Deviation 8.65
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	SBP - PK-tR: Pre-Infusion	3.5 Millimeter of mercury (mmHg)	Standard Deviation 9.15
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Blood Pressure	SBP - PK-tR: Post-Infusion	3.8 Millimeter of mercury (mmHg)	Standard Deviation 6.4
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	SBP - PK-tR: Pre-Infusion	1.0 Millimeter of mercury (mmHg)	Standard Deviation 14.54
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	DBP - PK-tR: Pre-Infusion	1.5 Millimeter of mercury (mmHg)	Standard Deviation 7.9
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	SBP - FDR: Pre-Infusion	1.8 Millimeter of mercury (mmHg)	Standard Deviation 12.87
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	SBP - PK-tR: Post-Infusion	4.9 Millimeter of mercury (mmHg)	Standard Deviation 15.14
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	DBP - FDR: Post-Infusion	0.4 Millimeter of mercury (mmHg)	Standard Deviation 9.21
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	DBP - FDR: Pre-Infusion	1.8 Millimeter of mercury (mmHg)	Standard Deviation 8.66
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	DBP - PK-tR: Post-Infusion	-0.9 Millimeter of mercury (mmHg)	Standard Deviation 7.93
BAX 855: Age >= 17 Years	Change From Baseline in Blood Pressure	SBP - FDR: Post-Infusion	-1.4 Millimeter of mercury (mmHg)	Standard Deviation 12.08

Secondary

Change From Baseline in Body Temperature

Change in body temperature at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.

Time frame: Baseline, end of study (53 months)

Population: SAS included all participants with at least 1 BAX 855 infusion. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Body Temperature	FDR: Pre-Infusion	-0.23 Degree celsius	Standard Deviation 0.208
BAX 855: Age < 2 Years	Change From Baseline in Body Temperature	FDR: Post-Infusion	-0.07 Degree celsius	Standard Deviation 0.306
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Body Temperature	PK-tR: Pre-Infusion	0.28 Degree celsius	Standard Deviation 0.255
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Body Temperature	PK-tR: Post-Infusion	0.13 Degree celsius	Standard Deviation 0.362
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Body Temperature	FDR: Pre-Infusion	-0.05 Degree celsius	Standard Deviation 0.386
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Body Temperature	FDR: Post-Infusion	-0.03 Degree celsius	Standard Deviation 0.394
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Body Temperature	PK-tR: Pre-Infusion	-0.08 Degree celsius	Standard Deviation 0.189
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Body Temperature	FDR: Pre-Infusion	-0.08 Degree celsius	Standard Deviation 0.409
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Body Temperature	PK-tR: Post-Infusion	0.03 Degree celsius	Standard Deviation 0.263
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Body Temperature	FDR: Post-Infusion	0.03 Degree celsius	Standard Deviation 0.375
BAX 855: Age >= 17 Years	Change From Baseline in Body Temperature	PK-tR: Post-Infusion	0.01 Degree celsius	Standard Deviation 0.593
BAX 855: Age >= 17 Years	Change From Baseline in Body Temperature	FDR: Pre-Infusion	-0.01 Degree celsius	Standard Deviation 0.376
BAX 855: Age >= 17 Years	Change From Baseline in Body Temperature	FDR: Post-Infusion	-0.02 Degree celsius	Standard Deviation 0.395
BAX 855: Age >= 17 Years	Change From Baseline in Body Temperature	PK-tR: Pre-Infusion	-0.10 Degree celsius	Standard Deviation 0.595

Secondary

Change From Baseline in Pain Severity

Hemophilia symptom (haemo-SYM) questionnaire has two subscales: pain and bleed. It was used to asses the pain severity for participants \>=18 years of age as: pain because of swelling in my joints, climbing stairs, upon waking in the morning, active arthritis; constant pain, in my muscles, that needs medication; joint sensitivity to weather conditions; reduced range of joint movement, joint deformity, sleep disturbance because of pain or bleeds, blood in my urine, nose bleeds and assigned a score of 0=Absent, 1=very mild, 2=mild, 3=moderate, 4=severe and 5=very severe. The score was determined as (mean score/5)\*100 where mean score is the mean of the available results in the particular subscale. Higher scores on the Haemo-SYM indicate more severe symptoms. Therefore, negative change scores indicate that symptoms have improved. Here 'n' refers to the number of participants evaluable for this endpoint.

Time frame: Baseline, end of study (53 months)

Population: FAS with population of age greater than or equal to 18 years were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Pain Severity	Fixed dose regimen	-1.341 Score on a scale	Standard Deviation 11.531
BAX 855: Age < 2 Years	Change From Baseline in Pain Severity	PK-tailored regimen	-8.889 Score on a scale	Standard Deviation 20.659

Secondary

Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire

HRQoL in participants aged \<14 years was measured using the PedsQL. It capture data for the following domains: physical functioning, emotional functioning, social functioning, school functioning, psychosocial functioning, physical health and a total score. Each question of the PedsQL was scored as Never: 100, almost never: 75, sometimes: 50, often: 25, almost always: 0. The mean of the individual question scores was calculated. Lower scores on the PedsQL indicating worse HRQoL. Here, FDR refers to fixed dose regimen, PK-t R refers to PK-tailored regimen. Here 'n' refers to the number of participants evaluable for this endpoint. Here 'n' refers to the number of participants evaluable for this endpoint.

Time frame: Baseline, end of study (53 months)

Population: FAS with population of age less than 14 years were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Physical functioning	0.534 Score on a scale	Standard Deviation 17.896
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Physical functioning	-0.446 Score on a scale	Standard Deviation 12.425
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Emotional functioning	-1.0 Score on a scale	Standard Deviation 16.93
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Emotional functioning	-2.1 Score on a scale	Standard Deviation 11.85
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Social functioning	-0.4 Score on a scale	Standard Deviation 16.22
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Social functioning	-6.4 Score on a scale	Standard Deviation 19.73
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: School functioning	3.472 Score on a scale	Standard Deviation 24.107
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: School functioning	-9.167 Score on a scale	Standard Deviation 16.591
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Psychosocial functioning	0.331 Score on a scale	Standard Deviation 15.283
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Psychosocial functioning	-6.099 Score on a scale	Standard Deviation 13.025
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Total score	0.366 Score on a scale	Standard Deviation 14.811
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Total score	-3.915 Score on a scale	Standard Deviation 12.201
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Total score	7.971 Score on a scale	Standard Deviation 15.23
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Physical functioning	3.125 Score on a scale	Standard Deviation 15.625
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: School functioning	15.000 Score on a scale	Standard Deviation 13.229
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Physical functioning	7.813 Score on a scale	Standard Deviation 6.629
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Psychosocial functioning	0.833 Score on a scale	Standard Deviation 3.536
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Emotional functioning	8.3 Score on a scale	Standard Deviation 20.21
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: School functioning	-12.500 Score on a scale	Standard Deviation 17.678
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Emotional functioning	10.0 Score on a scale	Standard Deviation 14.14
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Total score	3.261 Score on a scale	Standard Deviation 0
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Social functioning	8.3 Score on a scale	Standard Deviation 15.28
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	FDR: Psychosocial functioning	10.556 Score on a scale	Standard Deviation 15.486
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire	PK-t R: Social functioning	5.0 Score on a scale	Standard Deviation 7.07

Secondary

Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)

HRQoL in participants aged \>=14 years was measured using the SF-36 questionnaire. The questionnaire was divided into 8 domains and scored as: physical functioning (1=yes, limited a lot to 3=no, not limited at all), role-physical (1=all of the time to 5=none of the time), bodily pain (1=very severe to 6=none), general health (1=poor to 5=excellent), vitality (1=none of the time to 5=all of the time), social functioning (1=all of the time: to 5=none of the time), role emotional (1=all of the time to 5=none of the time) and mental health (1=all of the time to 5=none of the time). The score for each domain is then to be transformed to a 0-100 range as \[(actual raw score-lowest possible raw score)/possible raw score range\]\*100. Positive change scores indicate improved HRQoL. in the below table 'FDR' indicates fixed dose regimen, 'PK-tr' indicates pharmacokinetically tailored regimen and 'n' refers to the number of participants evaluable for this endpoint.

Time frame: Baseline, end of study (53 months)

Population: FAS with population of age greater than or equal to 14 years were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Role-physical	0.8 Score on a scale	Standard Deviation 4.13
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Social functioning	0.4 Score on a scale	Standard Deviation 1.69
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Bodily pain	-0.30 Score on a scale	Standard Deviation 2.687
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Social functioning	1.0 Score on a scale	Standard Deviation 1.41
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Physical functioning	1.000 Score on a scale	Standard Deviation 1.414
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Role emotional	-0.6 Score on a scale	Standard Deviation 2.26
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Role emotional	0.5 Score on a scale	Standard Deviation 0.71
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: General health	2.33 Score on a scale	Standard Deviation 3.533
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Mental health	-1.0 Score on a scale	Standard Deviation 1.93
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Role-physical	1.5 Score on a scale	Standard Deviation 3.54
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Mental health	0.5 Score on a scale	Standard Deviation 0.71
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: General health	2.30 Score on a scale	Standard Deviation 0.424
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Physical component score	8.280 Score on a scale	Standard Deviation 12.985
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Physical functioning	3.875 Score on a scale	Standard Deviation 4.912
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Physical component score	2.647 Score on a scale	Standard Deviation 7.99
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Vitality	-0.3 Score on a scale	Standard Deviation 3.2
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Mental component score	-4.780 Score on a scale	Standard Deviation 6.68
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Bodily pain	1.30 Score on a scale	Standard Deviation 2.53
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Mental component score	3.931 Score on a scale	Standard Deviation 7.769
BAX 855: Age < 2 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Vitality	2.5 Score on a scale	Standard Deviation 3.54
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Mental component score	-4.185 Score on a scale	Standard Deviation 8.634
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Physical functioning	-0.108 Score on a scale	Standard Deviation 3.021
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Physical functioning	-0.364 Score on a scale	Standard Deviation 4.456
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Role-physical	0.4 Score on a scale	Standard Deviation 3.9
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Role-physical	1.2 Score on a scale	Standard Deviation 2.86
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Bodily pain	0.81 Score on a scale	Standard Deviation 2.051
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Bodily pain	0.39 Score on a scale	Standard Deviation 3.25
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: General health	0.48 Score on a scale	Standard Deviation 3.837
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: General health	1.56 Score on a scale	Standard Deviation 4.328
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Vitality	0.1 Score on a scale	Standard Deviation 2.39
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Vitality	0.7 Score on a scale	Standard Deviation 3.8
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Social functioning	0.0 Score on a scale	Standard Deviation 1.39
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Social functioning	-1.2 Score on a scale	Standard Deviation 2.18
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Role emotional	-1.1 Score on a scale	Standard Deviation 2.47
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Mental health	-0.3 Score on a scale	Standard Deviation 3.17
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Mental health	-0.5 Score on a scale	Standard Deviation 2.7
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Physical component score	1.986 Score on a scale	Standard Deviation 7.059
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	PK-t R: Physical component score	3.414 Score on a scale	Standard Deviation 9.405
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Mental component score	-1.501 Score on a scale	Standard Deviation 9.059
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)	FDR: Role emotional	-0.4 Score on a scale	Standard Deviation 2.44

Secondary

Change From Baseline in Pulse Rate

Change in pulse rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.

Time frame: Baseline, end of study (53 months)

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Pulse Rate	FDR: Pre-Infusion	-20.3 Beats per minute (beats/min)	Standard Deviation 21.22
BAX 855: Age < 2 Years	Change From Baseline in Pulse Rate	FDR: Post-Infusion	-13 Beats per minute (beats/min)	Standard Deviation 19.47
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Pulse Rate	FDR: Pre-Infusion	-0.1 Beats per minute (beats/min)	Standard Deviation 14.31
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Pulse Rate	PK-tR: Post-Infusion	-8.1 Beats per minute (beats/min)	Standard Deviation 14.94
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Pulse Rate	FDR: Post-Infusion	2.4 Beats per minute (beats/min)	Standard Deviation 16.72
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Pulse Rate	PK-tR: Pre-Infusion	0.1 Beats per minute (beats/min)	Standard Deviation 9.13
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Pulse Rate	PK-tR: Pre-Infusion	-1.8 Beats per minute (beats/min)	Standard Deviation 13.91
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Pulse Rate	FDR: Post-Infusion	-6.2 Beats per minute (beats/min)	Standard Deviation 8.55
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Pulse Rate	FDR: Pre-Infusion	-7.7 Beats per minute (beats/min)	Standard Deviation 9.07
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Pulse Rate	PK-tR: Post-Infusion	-4.5 Beats per minute (beats/min)	Standard Deviation 12.4
BAX 855: Age >= 17 Years	Change From Baseline in Pulse Rate	FDR: Post-Infusion	-1 Beats per minute (beats/min)	Standard Deviation 10.07
BAX 855: Age >= 17 Years	Change From Baseline in Pulse Rate	PK-tR: Pre-Infusion	4.0 Beats per minute (beats/min)	Standard Deviation 9.15
BAX 855: Age >= 17 Years	Change From Baseline in Pulse Rate	PK-tR: Post-Infusion	-0.2 Beats per minute (beats/min)	Standard Deviation 7.31
BAX 855: Age >= 17 Years	Change From Baseline in Pulse Rate	FDR: Pre-Infusion	-0.4 Beats per minute (beats/min)	Standard Deviation 11.67

Secondary

Change From Baseline in Respiratory Rate

Change in respiratory rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.

Time frame: Baseline, end of study (53 months)

Arm	Measure	Group	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Change From Baseline in Respiratory Rate	FDR: Post-Infusion	-6.3 Breaths per minute (breaths/min)	Standard Deviation 4.73
BAX 855: Age < 2 Years	Change From Baseline in Respiratory Rate	FDR: Pre-Infusion	-6.3 Breaths per minute (breaths/min)	Standard Deviation 4.73
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Respiratory Rate	FDR: Pre-Infusion	-0.8 Breaths per minute (breaths/min)	Standard Deviation 3.97
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Respiratory Rate	PK-tR: Post-Infusion	0.4 Breaths per minute (breaths/min)	Standard Deviation 5.73
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Respiratory Rate	FDR: Post-Infusion	-1.3 Breaths per minute (breaths/min)	Standard Deviation 3.55
BAX 855: Age >= 2 to <12 Years	Change From Baseline in Respiratory Rate	PK-tR: Pre-Infusion	1.5 Breaths per minute (breaths/min)	Standard Deviation 7.01
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Respiratory Rate	FDR: Post-Infusion	-1.5 Breaths per minute (breaths/min)	Standard Deviation 1.85
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Respiratory Rate	FDR: Pre-Infusion	-1.3 Breaths per minute (breaths/min)	Standard Deviation 1.67
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Respiratory Rate	PK-tR: Post-Infusion	-3.3 Breaths per minute (breaths/min)	Standard Deviation 5.85
BAX 855: Age >= 12 to <17 Years	Change From Baseline in Respiratory Rate	PK-tR: Pre-Infusion	-3.5 Breaths per minute (breaths/min)	Standard Deviation 5.74
BAX 855: Age >= 17 Years	Change From Baseline in Respiratory Rate	PK-tR: Post-Infusion	0.3 Breaths per minute (breaths/min)	Standard Deviation 2.55
BAX 855: Age >= 17 Years	Change From Baseline in Respiratory Rate	FDR: Pre-Infusion	0.4 Breaths per minute (breaths/min)	Standard Deviation 2.85
BAX 855: Age >= 17 Years	Change From Baseline in Respiratory Rate	FDR: Post-Infusion	0.2 Breaths per minute (breaths/min)	Standard Deviation 2.88
BAX 855: Age >= 17 Years	Change From Baseline in Respiratory Rate	PK-tR: Pre-Infusion	0.2 Breaths per minute (breaths/min)	Standard Deviation 2.79

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an investigational product (IP), whether or not considered causally related to the IP. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death; was life-threatening; required inpatient hospitalization or resulted in prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a medically important event.

Time frame: Baseline through end of study (53 months)

Population: SAS included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAE	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAE	7 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE	52 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE	18 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAE	4 Participants
BAX 855: Age >= 17 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE	101 Participants
BAX 855: Age >= 17 Years	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAE	22 Participants

Secondary

Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies

Testing for binding of anti-CHO protein antibodies was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal antihuman IgG antibodies.

Time frame: Baseline through end of study (53 months)

Population: SAS included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies	0 Participants

Secondary

Number of Participants With Binding Antibodies

Binding antibodies (IgG and IgM) against FVIII, polyethylene glycol (PEG) and PEGylated FVIII (PEG-FVIII) were analyzed using enzyme-linked immunosorbent assay (ELISA).

Time frame: Baseline through end of study (53 months)

Population: SAS included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Binding Antibodies	IgG to FVIII	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Binding Antibodies	IgM to FVIII	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Binding Antibodies	IgG to PEG-FVIII	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Binding Antibodies	IgM to PEG-FVIII	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Binding Antibodies	IgG to PEG	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Binding Antibodies	IgM to PEG	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Binding Antibodies	IgM to PEG	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Binding Antibodies	IgM to PEG-FVIII	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Binding Antibodies	IgG to FVIII	2 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Binding Antibodies	IgG to PEG-FVIII	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Binding Antibodies	IgM to FVIII	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Binding Antibodies	IgG to PEG	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Binding Antibodies	IgM to FVIII	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Binding Antibodies	IgG to PEG-FVIII	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Binding Antibodies	IgM to PEG-FVIII	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Binding Antibodies	IgM to PEG	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Binding Antibodies	IgG to PEG	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Binding Antibodies	IgG to FVIII	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Binding Antibodies	IgG to PEG	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Binding Antibodies	IgM to PEG	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Binding Antibodies	IgM to FVIII	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Binding Antibodies	IgM to PEG-FVIII	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Binding Antibodies	IgG to FVIII	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Binding Antibodies	IgG to PEG-FVIII	4 Participants

Secondary

Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.

The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported. In the below table, FDR refers to fixed dose regimen at the time of sampling, AlA refers to alanine aminotransferase, AP refers to alkaline phosphatase, AsA refers to aspartate aminotransferase.

Time frame: Baseline through end of study (53 months)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Normal	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Normal	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Normal	43 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal NCS	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Normal	8 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Normal	11 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal NCS	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Normal	7 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Normal	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal NCS	9 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Normal	20 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Normal	20 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal CS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Normal	11 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Normal	11 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Normal	5 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Normal	15 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Normal	13 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal NCS	12 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Abnormal NCS	8 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal NCS to Normal	20 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Normal	6 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Normal	61 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal NCS	13 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal NCS	4 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Normal	82 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Normal to Abnormal NCS	6 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Abnormal NCS	7 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Abnormal NCS to Normal	5 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Abnormal CS	5 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Normal	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal NCS	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal CS	7 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Abnormal NCS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Normal to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Bilirubin- FDR: Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal NCS to Abnormal NCS	14 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Abnormal NCS	10 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Normal to Normal	100 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Normal to Normal	55 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal CS	4 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AP- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AlA- FDR: Abnormal CS to Abnormal CS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	AsA- FDR: Normal to Normal	53 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.	Glucose- FDR: Abnormal CS to Abnormal NCS	0 Participants

Secondary

Number of Participants With Shifts in Hematology Laboratory Assessments

The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, Leu refers to leukocytes, MCV refers to mean corpuscular volume, Lym/Leu refers to lymphocytes/leukocytes.

Time frame: Baseline through end of study (53 months)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Normal	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Normal	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Normal	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS toAbnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Normal	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR:Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Normal	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal NCS	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Normal	2 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR:Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Normal	37 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Normal	39 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Normal	7 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Normal	6 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Normal	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Normal	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal NCS	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Normal	5 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Normal	40 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Normal	28 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal NCS	5 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal NCS	5 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Normal	34 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS toAbnormal NCS	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Normal	37 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Normal	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Normal	34 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal NCS	3 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS toAbnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR:Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Normal	15 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal NCS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Normal	4 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Normal	13 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Normal	19 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Normal	11 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal NCS	6 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Normal	18 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Normal	20 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Normal	4 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Normal	21 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Normal	3 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR:Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Normal	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Abnormal NCS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal NCS to Normal	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal CS	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal NCS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Abnormal NCS	8 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Normal to Normal	70 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Normal to Normal	97 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal NCS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Normal	98 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS toAbnormal NCS	7 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Erythrocytes MCV- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- FDR: Normal to Normal	89 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Normal	10 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Abnormal NCS to Normal	6 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Normal to Normal	11 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal CS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Lym/Leu- FDR: Normal to Abnormal NCS	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Normal	88 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Abnormal NCS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Eosinophils/Leu- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Abnormal NCS to Normal	10 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Abnormal NCS	5 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- PK-t R: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hemoglobin- PK-t R: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Leukocytes- FDR: Normal to Normal	87 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Hematocrit- FDR: Normal to Normal	84 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Hematology Laboratory Assessments	Platelets- FDR: Normal to Abnormal CS	0 Participants

Secondary

Number of Participants With Shifts in Lipid Panel Assessments

The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported.. In the below table, HDL refers to high density lipoprotein, LDL refers to low density lipoprotein, VLDL refers to very low density lipoprotein.

Time frame: Baseline through end of study (53 months)

Population: SAS included all participants with at least 1 BAX 855 infusion.Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Normal	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS toAbnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Normal	3 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDLCholesterol-PK-tR:Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Normal	1 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age < 2 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS toAbnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Normal	8 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal NCS	5 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Normal	5 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal NCS	2 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Normal	7 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal NCS	2 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Normal	3 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal NCS	11 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Normal	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal NCS	7 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Normal	30 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Normal	7 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Normal	6 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDLCholesterol-PK-tR:Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 2 to <12 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS toAbnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal NCS	3 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	5 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDLCholesterol-PK-tR:Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Normal	10 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Normal	7 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal NCS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Normal	14 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Normal	3 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Normal	9 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal CS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal CS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal NCS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal CS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Normal	12 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	5 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal NCS	5 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Normal	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Normal	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Normal	4 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal CS	2 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Normal	3 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	1 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 12 to <17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Normal	84 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal NCS	8 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Normal	7 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal CS	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Normal to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Normal	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal CS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal NCS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal NCS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal NCS to Abnormal CS	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Abnormal NCS	13 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Normal to Normal	68 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Triglycerides- FDR: Abnormal CS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDLCholesterol-PK-tR:Abnormal NCS to Abnormal NCS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Normal	67 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Abnormal NCS	4 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal NCS	8 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Normal to Abnormal CS	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Normal	10 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal CS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS toAbnormal NCS	14 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR:Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal CS	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Normal	1 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol-PK-tR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Abnormal NCS	19 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Abnormal CS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Normal	56 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal NCS	9 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Normal	7 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Normal to Abnormal CS	3 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Abnormal NCS to Normal	8 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Normal	7 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	Cholesterol- FDR: Normal to Normal	65 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	20 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal CS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	VLDL Cholesterol- PK-tR: Normal to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Normal	2 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal CS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	LDL Cholesterol- FDR: Abnormal CS to Abnormal NCS	0 Participants
BAX 855: Age >= 17 Years	Number of Participants With Shifts in Lipid Panel Assessments	HDL Cholesterol- FDR: Abnormal NCS to Abnormal NCS	20 Participants

Secondary

Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes

The participant or caregiver rated the overall treatment response at 24 (+/- 2) hours after the initiation of treatment using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens.

Time frame: Baseline through end of study (53 months)

Population: FAS included all participants with at least 1 BAX 855 infusion. Here 'N' refers to the number of participants evaluable for this outcome.

Arm	Measure	Group	Value (NUMBER)
BAX 855: Age < 2 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Good	3 Treated bleeds
BAX 855: Age < 2 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	None	0 Treated bleeds
BAX 855: Age < 2 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Fair	0 Treated bleeds
BAX 855: Age < 2 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Not Reported	0 Treated bleeds
BAX 855: Age < 2 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Excellent	3 Treated bleeds
BAX 855: Age >= 2 to <12 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Not Reported	13 Treated bleeds
BAX 855: Age >= 2 to <12 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Excellent	108 Treated bleeds
BAX 855: Age >= 2 to <12 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Fair	5 Treated bleeds
BAX 855: Age >= 2 to <12 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Good	66 Treated bleeds
BAX 855: Age >= 2 to <12 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	None	0 Treated bleeds
BAX 855: Age >= 12 to <17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Not Reported	13 Treated bleeds
BAX 855: Age >= 12 to <17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	None	1 Treated bleeds
BAX 855: Age >= 12 to <17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Excellent	98 Treated bleeds
BAX 855: Age >= 12 to <17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Good	49 Treated bleeds
BAX 855: Age >= 12 to <17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Fair	7 Treated bleeds
BAX 855: Age >= 17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	None	3 Treated bleeds
BAX 855: Age >= 17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Fair	36 Treated bleeds
BAX 855: Age >= 17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Good	250 Treated bleeds
BAX 855: Age >= 17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Excellent	229 Treated bleeds
BAX 855: Age >= 17 Years	Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes	Not Reported	26 Treated bleeds

Secondary

Total Annualized Bleed Rate (ABR)

The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. Bleeding occurring at multiple locations related to the same injury (e.g., knee and ankle bleed following a fall) was counted as a single bleeding episode. Total annualized bleed rate (spontaneous and traumatic bleeding episodes) was reported.

Time frame: Baseline through end of study (53 months)

Population: FAS included all participants with at least 1 BAX 855 infusion.

Arm	Measure	Value (MEAN)	Dispersion
BAX 855: Age < 2 Years	Total Annualized Bleed Rate (ABR)	1.855 Bleeds per year	Standard Deviation 1
BAX 855: Age >= 2 to <12 Years	Total Annualized Bleed Rate (ABR)	2.370 Bleeds per year	Standard Deviation 3.027
BAX 855: Age >= 12 to <17 Years	Total Annualized Bleed Rate (ABR)	3.175 Bleeds per year	Standard Deviation 2.797
BAX 855: Age >= 17 Years	Total Annualized Bleed Rate (ABR)	2.426 Bleeds per year	Standard Deviation 3.258

Secondary

Total Time Intervals Between Bleeding Episodes

The time interval between bleeding episodes was calculated based upon the date and time reported for each bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.

Time frame: Baseline through end of study (53 months)

Population: FAS included all participants with at least 1 BAX 855 infusion. Here number of participants analyzed refers to the number of participants evaluable for this outcome.

Arm	Measure	Value (MEDIAN)
BAX 855: Age < 2 Years	Total Time Intervals Between Bleeding Episodes	5.700 Months
BAX 855: Age >= 2 to <12 Years	Total Time Intervals Between Bleeding Episodes	5.051 Months
BAX 855: Age >= 12 to <17 Years	Total Time Intervals Between Bleeding Episodes	5.232 Months
BAX 855: Age >= 17 Years	Total Time Intervals Between Bleeding Episodes	5.818 Months

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026

BAX 855 Continuation

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Annualized Bleed Rate (ABR) - Spontaneous Bleeds

Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)

Average Dose of BAX 855 Per Prophylactic Infusion

BAX 855 Infusions Needed to Treat Bleeding Episodes

Change From Baseline in Bleed Severity

Change From Baseline in Blood Pressure

Change From Baseline in Body Temperature

Change From Baseline in Pain Severity

Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire

Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)

Change From Baseline in Pulse Rate

Change From Baseline in Respiratory Rate

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies

Number of Participants With Binding Antibodies

Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.

Number of Participants With Shifts in Hematology Laboratory Assessments

Number of Participants With Shifts in Lipid Panel Assessments

Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes

Total Annualized Bleed Rate (ABR)

Total Time Intervals Between Bleeding Episodes