Study to Assess the Efficacy and Safety of Emapalumab in... | NCT03312751

Label	Type	Description	Intervention Names
Emapalumab	Experimental		Drug: Emapalumab

Name	Type	Description	Arm Group Labels	Other Names
Emapalumab	Drug	Emapalumab will be administered by intravenous infusion, twice weekly.	Emapalumab

Measure	Description	Time Frame
Overall Response at Week 8 or End of Treatment (if Earlier)	The overall response rate (ORR) of patients achieving either Complete or Partial Response or HLH Improvement, at Week 8 or EOT (whichever occurs earlier).	Up to Week 8

Measure	Description	Time Frame
Overall Survival at End of Study	Number of patients surviving to the end of the study.	Up to 18 months
Overall Survival to HSCT	Number of patients surviving to HSCT.

Measure	Description	Time Frame
Serum Concentrations of Emapalumab	The serum concentration of emapalumab will be measured as a function of time to determine the emapalumab PK profile.	Up to Week 8, with data presented at Baseline and EOT/W8
Change in Pharmacodynamic Parameters

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children Hospital		Phoenix	Arizona	85016	United States
Children's Hospital Los Angeles

ID	Title	Description
FG000	All-treated Analysis Set - Treatment naïve	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints. Details are reported in this arm for patients in the All-treated analysis set who were naïve to HLH treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 31, 2020	Sep 4, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Response at Week 8 or End of Treatment (if Earlier)

The overall response rate (ORR) of patients achieving either Complete or Partial Response or HLH Improvement, at Week 8 or EOT (whichever occurs earlier).

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Week 8

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units	Counts
Participants	OG00035 OG00116 OG00219

Title

Denominators

Categories

Title	Measurements
	OG00062.9(44.9 to 78.5) OG00150.0(24.7 to 75.3) OG00273.7(48.8 to 90.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.	Exact binomial		0.0053		Overall response rate	62.9			2-Sided	95	44.9	78.5					Superiority
OG001

Secondary

Overall Survival at End of Study

Number of patients surviving to the end of the study.

'All-treated analysis set - treatment experienced' includes a censored observation for 1 patient who discontinued the study early.

Posted

Count of Participants

Participants

Up to 18 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Secondary

Overall Survival to HSCT

Number of patients surviving to HSCT.

Posted

Count of Participants

Participants

From start of treatment to HSCT or from start of treatment until 1 year after EOT for patient who did not undergo HSCT

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units	Counts

Secondary

Overall Survival for Patients Receiving HSCT

Number of patients surviving post HSCT.

All-treated analysis includes total number or patients who received HSCT.

Posted

Count of Participants

Participants

Up to 1 year post HSCT

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Secondary

Event-free Survival

Number of patients experiencing event-free survival, the duration of which was defined as time from HSCT to date of (whichever occurs first): death from any cause, graft failure, or HLH reactivation.

Analysis population based on the number of patients with HSCT.

Posted

Count of Participants

Participants

Up to 1 year post HSCT

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Secondary

Overall Response at Start of Conditioning

Number of patients achieving either a Complete or Partial Response or HLH Improvement, at start of conditioning (or at last emapalumab infusion if HSCT is not performed).

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units

Secondary

Duration of Response

Duration of response, i.e., maintenance of the response achieved at any time during the study (with censoring time at start of conditioning for patients with no event) calculated only for patients showing confirmed overall response. Summarized by number of patients experiencing each category of response duration.

Only patients showing at least one maintained response were included. Duration of response is defined as maintenance of response for at least 4 days, achieved at any time during the study until EOT. Patients who do not achieve at least HLH improvement between the date of first dose and EOT are excluded from the analysis. For both first response and loss of response, persistence for at least 4 days is required, otherwise the next response/loss of response period will be considered.

Posted

Median

95% Confidence Interval

days

Up to 18 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced

Secondary

Time to Response

Time to first response at any time during the study.

Only patients with a response were included.

Posted

Median

95% Confidence Interval

days

Up to 18 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units	Counts

Secondary

Number of Patients Reducing Glucocorticoids by 50% or More of the Baseline Dose During Emapalumab Treatment

Number of patients able to reduce glucocorticoids by 50% or more of the baseline dose during emapalumab treatment.

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Secondary

Number of Patients Proceeding to HSCT

Number of patients able to proceed to HSCT when deemed indicated.

Posted

Count of Participants

Participants

Up to 18 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units	Counts
Participants

Secondary

Quality of Life Assessed Through PedsQL™, Pediatric Quality of Life Inventory™

Assessment of the quality of life using the PedsQL "Pediatric Quality of Life Inventory". The PedsQL uses a 100-point scale ranging from 0 to 100 with higher values indicating better quality of life.

Results from the PedsQL were not available for all patients; in addition, due to the age and treatment history of patients, not all age categories were represented in each of the analysis sets.

Posted

Mean

Standard Deviation

scale on a score

Up to 6 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Secondary

Quality of Life Assessed Through Behavioral, Affective and Somatic Experiences Scales (BASES)

Assessment of the quality of life using the BASES questionnaire, which is a validated 38-item questionnaire; a reduced nonvalidated 22-item version of the questionnaire is used in an exploratory nature for the secondary endpoint.

Subscale scores were calculated using a 5-point Likert scale from 1 to 5 for all questions. Scores for all questions in each subscale were added up and divided by the number of patients in the analysis population to reach the mean score. Subscale scores were calculated for the following domains:

Physical Discomfort (5 questions, '1' = best response, total range 5-25)
Cooperation/Compliance (5 questions, '1' = best response, total range 5-25)
Mood/Behavior (7 questions, '5' = best response, total range 7-35)
Quality of Interactions (3 questions, '1' = best response, total range 3-15)
Activity/Sleep (2 questions, '5' = best response for patient's activity level and '1' = best response for patient's sleeping, total range 2-10)

Assessment completed at the end of treatment for those who proceeded/were planned to proceed to HSCT.

Posted

Mean

Standard Deviation

scale on a score

Up to 6 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve

Secondary

Incidence, Severity, Causality and Outcomes of AEs (Serious and Non-serious)

Incidence of adverse events. SAE = serious adverse event; TEAE = treatment-emergent adverse event

Posted

Count of Participants

Participants

Up to 18 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units	Counts

Secondary

Evolution of Laboratory Parameters Change From Baseline to EOT/Week 8

Number of patients experiencing shifts from baseline in the following relevant laboratory parameters are reported:

Biochemistry: glucose ferritin, C-reactive protein (CRP), liver function (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma glutamyl transferase [γGT], lactate dehydrogenase [LDH], bilirubin, renal function (albumin, creatinine, urea, urea nitrogen), triglycerides
Complete blood count: basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, large unstained cells, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils band form, neutrophils band form/leukocytes, platelets, erythrocytes, leukocytes
Coagulation tests (activated partial thromboplastin time [aPTT], aPTT ratio, prothrombin time, prothrombin international normalized ratio [INR]), D-dimer, fibrinogen

Posted

Count of Participants

Participants

To Week 8 or End of treatment if before Week 8.

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.

Secondary

Number of Patients Who Discontinued Emapalumab Treatment

Number of patients who discontinued emapalumab treatment for safety reasons.

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Units	Counts

Other Pre-specified

Serum Concentrations of Emapalumab

The serum concentration of emapalumab will be measured as a function of time to determine the emapalumab PK profile.

The number of participants analyzed at each timepoint reflects the number of participants who provided samples.

Posted

Mean

Standard Deviation

ng/mL

Up to Week 8, with data presented at Baseline and EOT/W8

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Other Pre-specified

Change in Pharmacodynamic Parameters

Levels (in ng/L) of total IFNγ (interferon gamma), markers of its neutralization (CXCL9 and CXCL10), and sCD25.

The number of participants analyzed at each timepoint reflects the number of participants who provided samples.

Posted

Mean

Standard Deviation

ng/L

Up to 18 months with data presented at Baseline and EOT/W8

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Other Pre-specified

Number of Patients Who Demonstrated a Presence of Circulating Antibodies Against Emapalumab to Determine Immunogenicity

The presence of circulating antibodies against emapalumab was inferred by positive results for anti-drug antibodies (ADAs).

Number of patients who demonstrated a presence of circulating antibodies shown only for visits where a positive result was recorded.

Posted

Count of Participants

Participants

Up to 1 year follow up post end of treatment with assessments at first dose of emapalumab, Week 4, Week 8, EOT and following treatment at day 100 and at the 1 year follow up visit, with data presented at study day 21 and EOT/Week 8.

ID	Title	Description
OG000	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.
OG001	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.
OG002	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Condition aggravated	General disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected16 at risk EG0018 events8 affected19 at risk EG00212 events12 affected35 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0014 events4 affected19 at risk EG0025 events5 affected35 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0013 events3 affected19 at risk EG0025 events5 affected35 at risk
Catheter site haemorrhage	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pneumonia viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected19 at risk EG0023 events3 affected35 at risk
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0013 events2 affected19 at risk EG0024 events3 affected35 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Septic shock	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Bacterial sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Bronchiolitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Encephalitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Enterococcal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Epstein-Barr virus infection reactivation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Herpes simplex viraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Staphylococcal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events2 affected19 at risk EG0024 events4 affected35 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected16 at risk EG0012 events2 affected19 at risk EG0025 events4 affected35 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0004 events3 affected16 at risk EG0010 events0 affected19 at risk EG0024 events3 affected35 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Seizure	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events3 affected19 at risk EG0023 events3 affected35 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Nervous system disorder	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Neurological decompensation	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0013 events3 affected19 at risk EG0024 events4 affected35 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected19 at risk EG0023 events3 affected35 at risk
Cardiac arrest	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Cardiac failure	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Engraftment syndrome	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Acute graft versus host disease	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Shock	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Venoocclusive disease	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Graft loss	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Fanconi syndrome	Congenital, familial and genetic disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Visual field defect	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Klebsiella test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Epstein-Barr virus associated lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00010 events7 affected16 at risk EG00115 events10 affected19 at risk EG00225 events17 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0007 events5 affected16 at risk EG00116 events10 affected19 at risk EG00223 events15 affected35 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events2 affected16 at risk EG0016 events5 affected19 at risk EG00211 events7 affected35 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0017 events4 affected19 at risk EG0029 events6 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0013 events3 affected19 at risk EG0025 events5 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0013 events2 affected19 at risk EG0025 events4 affected35 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected19 at risk EG0023 events3 affected35 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Anal erythema	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Anal blister	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Ascites	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Dyschezia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Flatulence	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gastrointestinal wall thickening	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Mouth swelling	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Oral pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG00011 events6 affected16 at risk EG00117 events8 affected19 at risk EG00228 events14 affected35 at risk
Pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0007 events3 affected16 at risk EG0019 events6 affected19 at risk EG00216 events9 affected35 at risk
Mucosal inflammation	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0014 events4 affected19 at risk EG0025 events5 affected35 at risk
Oedema peripheral	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0015 events2 affected19 at risk EG0026 events4 affected35 at risk
Condition aggravated	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Hypothermia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Catheter site rash	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Crying	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected19 at risk EG0023 events1 affected35 at risk
Generalised oedema	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Malaise	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Oedema	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Vascular device occlusion	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0006 events4 affected16 at risk EG0017 events4 affected19 at risk EG00213 events8 affected35 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0004 events3 affected16 at risk EG0012 events2 affected19 at risk EG0026 events5 affected35 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0015 events4 affected19 at risk EG0026 events5 affected35 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected16 at risk EG0012 events2 affected19 at risk EG0025 events4 affected35 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0017 events4 affected19 at risk EG0027 events4 affected35 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Livedo reticularis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0004 events3 affected16 at risk EG0012 events1 affected19 at risk EG0026 events4 affected35 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0014 events3 affected19 at risk EG0025 events4 affected35 at risk
Bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0013 events2 affected19 at risk EG0024 events3 affected35 at risk
Candida infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events1 affected19 at risk EG0024 events3 affected35 at risk
Adenovirus reactivation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Epstein-Barr virus infection reactivation	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Fungal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Oral fungal infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Paronychia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Rhinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Skin infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Adenovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Bacterial disease carrier	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0014 events1 affected19 at risk EG0024 events1 affected35 at risk
Bacterial sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected19 at risk EG0022 events1 affected35 at risk
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Enterocolitis viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected19 at risk EG0022 events1 affected35 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Influenza	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Lymph gland infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Norovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Oral candidiasis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pneumonia fungal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Sepsis neonatal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Systemic candida	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Viral infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events1 affected16 at risk EG0010 events0 affected19 at risk EG0023 events1 affected35 at risk
Adenovirus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0013 events2 affected19 at risk EG0024 events3 affected35 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events3 affected19 at risk EG0023 events3 affected35 at risk
C-reactive protein increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected19 at risk EG0023 events3 affected35 at risk
Platelet count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events3 affected19 at risk EG0023 events3 affected35 at risk
Weight increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected19 at risk EG0023 events3 affected35 at risk
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Fibrin D dimer increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Gram stain positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Haemoglobin decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Human rhinovirus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Respirovirus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Bacterial test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Blood creatinine decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Blood glucose decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Blood magnesium decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Candida test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Culture	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cytomegalovirus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Enterobacter test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Epstein-Barr virus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
General physical condition abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0020 events0 affected35 at risk
Glycocholic acid increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Klebsiella test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Oxygen saturation decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pseudomonas test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Sapovirus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Staphylococcus test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Ultrasound abdomen abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Ultrasound kidney abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Ultrasound liver abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Urine output decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Vitamin D increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected16 at risk EG0013 events3 affected19 at risk EG0026 events5 affected35 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events1 affected19 at risk EG0023 events2 affected35 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected16 at risk EG0012 events1 affected19 at risk EG0024 events2 affected35 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events2 affected19 at risk EG0023 events2 affected35 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Interstitial lung abnormality	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected16 at risk EG0016 events4 affected19 at risk EG0029 events7 affected35 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events2 affected19 at risk EG0024 events4 affected35 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0013 events2 affected19 at risk EG0024 events3 affected35 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected19 at risk EG0022 events1 affected35 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Iron overload	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected16 at risk EG0015 events5 affected19 at risk EG00211 events11 affected35 at risk
Hypotension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events1 affected19 at risk EG0024 events3 affected35 at risk
Haematoma	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Venoocclusive disease	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected16 at risk EG0011 events1 affected19 at risk EG0024 events3 affected35 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected19 at risk EG0023 events3 affected35 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected19 at risk EG0022 events2 affected35 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0020 events0 affected35 at risk
Hypofibrinogenaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected16 at risk EG0014 events4 affected19 at risk EG0027 events7 affected35 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0015 events3 affected19 at risk EG0026 events4 affected35 at risk
Bradycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Hypotonia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Cerebral ventricle dilatation	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Dyskinesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Leukoencephalopathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Myoclonus	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Nervous system disorder	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Seizure	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected16 at risk EG0011 events1 affected19 at risk EG0024 events4 affected35 at risk
Nephrocalcinosis	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Azotaemia	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Glycosuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Kidney enlargement	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0020 events0 affected35 at risk
Proteinuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cell-mediated immune deficiency	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Chronic graft versus host disease in skin	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Graft versus host disease in liver	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Graft versus host disease in skin	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Immune system disorder	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gallbladder enlargement	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Gallbladder oedema	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Liver injury	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Anal injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events1 affected19 at risk EG0024 events3 affected35 at risk
Perineal injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Genital injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events2 affected19 at risk EG0024 events4 affected35 at risk
Adrenal suppression	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Cushingoid	Endocrine disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected19 at risk EG0022 events2 affected35 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Spinal deformity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Eyelid oedema	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected19 at risk EG0022 events2 affected35 at risk
Blepharitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Eye swelling	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected19 at risk EG0022 events1 affected35 at risk
Glaucoma	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Lagophthalmos	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Ocular hyperaemia	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Periorbital oedema	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Swelling of eyelid	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Agitation	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Confusional state	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Delirium	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Irritability	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected19 at risk EG0022 events1 affected35 at risk
Restlessness	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Umbilical granuloma	Pregnancy, puerperium and perinatal conditions	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected19 at risk EG0021 events1 affected35 at risk
Pain management	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk
Vitamin supplementation	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected19 at risk EG0021 events1 affected35 at risk

ID	Term
D015616	Histiocytosis, Non-Langerhans-Cell
D015614	Histiocytosis
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Title	Description
BG000	All-treated Analysis Set - Treatment naïve	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints. Details are reported in this arm for patients in the All-treated analysis set who were naïve to HLH treatment.
BG001	All-treated Analysis Set - Treatment Experienced	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints. Details are reported in this arm for patients in the All-treated analysis set who have received conventional HLH therapy (as per site standard of care), without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All-treated Analysis Set - Treatment naïve	Patients in the All-treated analysis set who were naïve to HLH treatment.	7	16	16	16	14	16
EG001	All-treated Analysis Set - Treatment Experienced	Patients in the All-treated analysis set who could have received conventional HLH therapy without having obtained a satisfactory response according to the Investigator or having shown signs of intolerance to previous HLH therapy.	9	19	16	19	19	19
EG002	All-treated Analysis Set	The All-treated analysis set included all patients who received any part of an infusion of study drug. The All-treated analysis set was the primary analysis set for efficacy endpoints and was used for safety and PK/PD endpoints.	16	35	32	35	35	35