Reparixin add-on Therapy to Standard Care to Limit Progre... | NCT05254990

ID	Type	Description	Link
2021-006951-32	EudraCT Number

Status Module

Description Module

Detailed Description

Multinational, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III trial.

This study was conducted at 101 sites across 7 countries (Argentina, Australia, Austria, Germany, Italy, Turkey, and the United States [US]) that enrolled 414 male and female patients > 18 years of age, hospitalized for CAP (including COVID-19). Please note that of these 101 sites, only 74 had enrolled patients and, hence, have been reported on CT.gov.

The maximum study duration for a participant was 180 days, which included screening (day -1 or 1), treatment (up to day 21), and follow-up period (up to day 180).

Of the 414 patients enrolled, 409 (98.8%) were randomized 1:1 to receive investigational products (oral reparixin [N = 205] or matched placebo [N = 204], three times a day (TID), for up to 21 days. Randomization was stratified according to disease severity and site.

Actually, 394 participants (96.3%)(oral reparixin [N = 201] or matched placebo [N = 193]) received at least 1 dose of the investigational product and hence were included in the FAS population.

All the patients received the Standard of Care (SoC) based on their clinical need, including COVID-19 and CAP medications, as per local standard therapy at the trial site and in line with international guidelines.

Of the randomized population (N = 409), 186 participants (45.5%) completed the study; 223 (54.5%) discontinued the study prematurely.

The primary outcome was evaluated at day 28, while the secondary outcomes were scheduled to be evaluated from day 3 to day 180.

An independent external data monitoring committee (DMC) oversaw the study and evaluated unblinded interim data for efficacy, futility, and safety.

The interim efficacy analysis met the pre-specified criteria for futility and the DMC recommended early termination of the study. Based on the recommendation of the DMC, Dompé decided to terminate the study earlier than planned. The decision was not related to any safety concerns.

Due to the early study termination and not reaching the planned enrollment target, the outcome measure analyses were conducted for descriptive purposes only.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reparixin + standard of care (SoC)	Experimental	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours.	Drug: Reparixin
Placebo + standard of care (SoC)	Placebo Comparator	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reparixin	Drug	Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Patients Dead or Requiring Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO) by Day 28 [NIAID-OS 7].	The primary endpoint was based on NIAID-OS ordinal scale (National Institute of Allergy and Infectious Disease) with score OS 7 which means patients "hospitalized, on invasive mechanical ventilation or ECMO". The scores on this scale of Disease severity range from OS 1 (best outcome) to OS 8 (worst outcome). NIAID-OS (National Institute of Allergy and Infectious Disease Ordinal Scale) SCORE Descriptor: OS 1 Not hospitalized, no limitations on activities; OS 2 Not hospitalized, limitation on activities and/or requiring home O2; OS 3 Hospitalized, no supplemental O2 - no longer requires ongoing medical care; OS 4 Hospitalized, no supplemental O2 - requiring ongoing medical care; OS 5 Hospitalized, requiring supplemental O2; OS 6 Hospitalized, on non-invasive ventilation or high-flow oxygen devices; OS 7 Hospitalized, on invasive mechanical ventilation or ECMO; OS 8 Death;	Day 28

Secondary Outcomes

Measure	Description	Time Frame
All-cause Mortality by Day 180	Key secondary endpoint. All-cause mortality is a measurement of the total number of deaths from any cause within a specific population over a defined period. It is a broad metric used in medical research and public health to assess overall population health, identify risk factors for premature death, and evaluate the effectiveness of interventions. The number of participants (in the form of unadjusted proportion) who met the endpoint is reported.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent signed
Male and female ≥18 years old;
Patients hospitalized for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission):
1. at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum, crackles (rales) and/or rhonchi
2. body temperature > 38°C or <36°C (before or during admission) or leucocytosis (> local ULN)
3. new/increased pulmonary infiltrate(s) by chest imaging
Need for non-invasive supplemental oxygen (NIAID-OS 5-6);
SpO2 <92% at room air, or PaO2/FiO2 (or SpO2/FiO2) <300;
Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:
1. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last IMP dose
2. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last IMP dose
3. A male sexual partner who agrees to use a male condom with spermicide
4. A sterile sexual partner

Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake.

Exclusion Criteria:

Treatment with IMV or ECMO (NIAID-OS 7);
Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score B or C);
Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) <50 mL/min/1.73 m2, or need for haemodialysis or hemofiltration;
Current use of >2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC < local LLN), solid organ or bone marrow transplant recipients)
Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period;
Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening
History of:
1. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion)
2. lactase deficiency, galactosemia or glucose-galactose malabsorption
3. gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage
4. allergy to reparixin or any component of the IMP formulation
Active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage
Participation in other interventional clinical trials
Clinical condition not compatible with oral administration of the study drug
Pregnancy:
1. positive or missing pregnancy test before first drug intake or day 1;
2. pregnant or lactating women;
3. women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study
Current hospital stay >72h
Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

Name	Affiliation	Role
Giovanni Landoni, MD	IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
MD Banner University Medical Center /Arizona University		Tucson	Arizona	85719	United States
UCI Health

PubMed Identifier	Type	Citation	Retractions
40028879	Derived	Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 20, 2022	Oct 20, 2025

Arm/Group Information

ID	Title	Description
BG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
BG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
BG002	Total	Total of all reporting groups

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

Proportion of Patients Dead or Requiring Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO) by Day 28 [NIAID-OS 7].

The primary endpoint was based on NIAID-OS ordinal scale (National Institute of Allergy and Infectious Disease) with score OS 7 which means patients "hospitalized, on invasive mechanical ventilation or ECMO".

The scores on this scale of Disease severity range from OS 1 (best outcome) to OS 8 (worst outcome).

NIAID-OS (National Institute of Allergy and Infectious Disease Ordinal Scale)

SCORE Descriptor:

OS 1 Not hospitalized, no limitations on activities;
OS 2 Not hospitalized, limitation on activities and/or requiring home O2;
OS 3 Hospitalized, no supplemental O2 - no longer requires ongoing medical care;
OS 4 Hospitalized, no supplemental O2 - requiring ongoing medical care;
OS 5 Hospitalized, requiring supplemental O2;
OS 6 Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
OS 7 Hospitalized, on invasive mechanical ventilation or ECMO;
OS 8 Death;

The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 312 had primary endpoint data (n=160 in the reparixin arm and n=152 in the placebo arm).

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Units	Counts
Participants	OG000160 OG001152

Title

Denominators

Categories

Title	Measurements
	OG0007 OG00112

Secondary

All-cause Mortality by Day 180

Key secondary endpoint. All-cause mortality is a measurement of the total number of deaths from any cause within a specific population over a defined period. It is a broad metric used in medical research and public health to assess overall population health, identify risk factors for premature death, and evaluate the effectiveness of interventions. The number of participants (in the form of unadjusted proportion) who met the endpoint is reported.

FAS:All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 212 had available all-cause mortality data at day 180 (n=104 for reparixin arm and n=108 for placebo arm)

Posted

Count of Participants

Participants

Day 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Proportion of Patients Alive and Discharged From the Hospital by Day 28

Key secondary endpoint. The number of participants alive or discharged, expressed in the form of unadjusted proportion, who met the endpoint at the final analysis at day 28 is provided.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, only 350 had available endpoint data (n=179 for reparixin arm and n=171 for placebo arm).

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care

Secondary

Ventilatory-free Days (VFD) by Day 28

Key secondary endpoint. Number of days from Day 0 to Day 28 when the patient was alive and free of invasive ventilation is reported. In case of multiple periods of IMV during the first 28 days, the total duration of ventilation considered all periods of ventilation during the index admission. Patients who died within 28 days or who still were on invasive ventilation after 28 days were scored 0 VFDs.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 179 participants in the reparixin group and 171 participants in the placebo group were evaluable for the endpoint of ventilatory-free days at day 28.

Posted

Mean

Standard Deviation

number of days

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Proportion of Patients With IMV (or ECMO) by Day 28

Key secondary endpoint.The number of participants, expressed in the form of unadjusted proportion, who met the endpoint at the final analysis is reported.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 309 had available endpoint data (n=159 in the reparixin arm and n= 150 in the placebo group).

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Length of Primary Hospital Stay (in Days)

Key secondary endpoint. The duration of primary hospital stay, expressed in days, are reported. This parameter is included in the set of final evaluation, which comprises: no. of days of hospitalization, etiologic agents (if identified), ICU admission and total days in ICU, occurrence, and duration of IMV and/or ECMO, if any.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 191 participants in the reparixin group and 184 participants in the placebo group were evaluable for the endpoint.

Posted

Mean

Standard Deviation

days of hospital stay

Day 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001

Secondary

Clinical Failure by Day 3 and Day 7

Clinical failure was defined as the occurrence of IMV/ECMO or vasopressor, or death.

IMV= invasive mechanical ventilation. ECMO=extracorporeal membrane oxygenation.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. No. of evaluable patients by day 3: n=195 in the reparixin group and n=186 in the placebo group. No. of evaluable patients by day 7: n=184 in the reparixin group and n=177 in the placebo group.

Posted

Count of Participants

Participants

Day 3 and Day 7

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care

Secondary

28-day ICU-free Days

ICU-free days = days of hospitalization out of the Intensive Care Unit. Death within Day 28 was handled as an unfavorable event and ICU-free days were set at 0.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 179 participants in the reparixin group and 171 participants in the placebo group were evaluable for the endpoint.

Posted

Mean

Standard Deviation

days

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Days Free of IMV or ECMO (Number of Days With NIAID-OS 1-6) by Day 28

These parameters are expressed as number of days with NIAID-OS score not equal to 7 or 8, where NIAID-OS is the National Institute of Allergy and Infectious Disease Ordinal Scale; a scale ranging from 1 to 8, where the lower the score, the better the outcome.

The IMV/ECMO-free days at Day 28 were analyzed according to MI approach and ANOVA model. Death due to progression of the respiratory disease within Day 28 was handled as an unfavorable event and IMV/ECMO-free days at Day 28 was set at 0.

FAS: All randomized patients who received at least one dose of the investigational product.

FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.

The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 179 in the reparixin group and 169 in the placebo group were evaluable for this endpoint at day 28.

Posted

Mean

Standard Deviation

days

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Duration of Antibiotic Therapy (Days) by Day 28

A descriptive summary of duration of antibiotic therapy (days) at day 28 for the FAS is reported.

FAS: All randomized patients who received at least one dose of the investigational product.

FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.

The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 175 in the reparixin group and 163 in the placebo group were evaluable for this endpoint.

Posted

Mean

Standard Deviation

days

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Hospital Free Days

Results for hospital-free days at day 28 in the FAS are presented through an unadjusted descriptive summary.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 179 participants in the reparixin group and 171 participants in the placebo group were evaluable for this endpoint.

Posted

Mean

Standard Deviation

days

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Proportion of Patients Recovered

Results for the proportion of participants recovered at fixed timepoints in the FAS are presented. Recovering was defined as a downward shift from screening of ≤2 points on the NIAID-OS or live discharge from hospital. Unadjusted proportion is reported.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data.

No of patients evaluable:

Day 3: n=184 REP; n=178 Placebo (P) Day 7: n=129 REP; n=128 P Day 14: n=165 REP; n=159 P Day 21: n=40 REP; n=38 P Day 28: n=159 REP; n=154 P HD: n=183 REP; n=177 P

Posted

Count of Participants

Participants

days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001

Secondary

Proportion of Patients Worsening

Results for the proportion of participants worsening at fixed timepoints in the FAS are presented.

Worsening was expressed as upward shift from screening of at least >1 point of the NIAID-OS or if patient died before X Visit Day. An unadjusted proportion is reported.

No of patients evaluable:

Day 3: n=184 REP; n=178 Placebo (P) Day 7: n=129 REP; n=128 P Day 14: n=165 REP; n=159 P Day 21: n=40 REP; n=38 P Day 28: n=159 REP; n=154 P HD: n=183 REP; n=177 P

Posted

Count of Participants

Participants

days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001

Secondary

Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)

Descriptive statistics for the change from baseline in arterial partial pressure of oxygen (PaO2) at fixed timepoints are reported.

No of patients evaluable:

Day 3: n=180 REP; n=178 Placebo (P) Day 7: n=124 REP; n=126 P Day 14: n=108 REP; n=98 P Day 21: n=27 REP; n=18 P Day 28: n=82 REP; n=75 P HD: n=3 REP; n=2 P

Posted

Mean

Standard Deviation

mmHg

days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care

Secondary

Change From Baseline in Pulse Oximetry (SpO2)

Descriptive statistics for the change from baseline in pulse oximetry, measured as peripheral arterial oxygen saturation (SpO2), at fixed timepoints are reported.

No. of patients evaluable:

Day 3: n=180 REP; n=177 Placebo (P) Day 7: n=123 REP; n=124 P Day 14: n=107 REP; n=98 P Day 21: n=27 REP; n=18 P Day 28: n=82 REP; n=75 P HD: n=3 REP; n=2 P

Posted

Mean

Standard Deviation

percent hemoglobin oxygen saturation

days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care

Secondary

Change From Baseline in Inspired Oxygen (FiO2) Levels

FiO2 is a parameter of lung function representing the fraction of oxygen in the inspired air, ranging from 0.21 (room air) to 1.00 (100% oxygen). The endpoint assesses the change from baseline in FiO2 levels at predefined timepoints during the study.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data.

Subjects who contributed data per row Day 3: REP n=167; P n=171 Day 7±1: REP n=116; P n=123 Day 14±2: REP n=102; P n=93 Day 21±2: REP n=27; P n=18 Day 28±2: REP n=75; P n=71 HD: REP n=2; P n=1

Posted

Mean

Standard Deviation

fraction (0.21-1.00)

days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Change From Baseline in PaO2/FiO2 Ratio

The PaO2/FiO2 ratio is a parameter of lung function that reflects the efficiency of oxygen transfer from the lungs to the blood. It is calculated as the ratio between the arterial partial pressure of oxygen (PaO2, measured in mmHg) and the fraction of inspired oxygen (FiO2, expressed as a fraction ranging from 0.21 to 1.00). This endpoint assesses the change from baseline in the PaO2/FiO2 ratio at predefined timepoints during the study.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Only those participants with data available at specified timepoints have been presented.

Posted

Mean

Standard Deviation

ratio

days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Change From Baseline in SpO2/FiO2 Ratio

The SpO2/FiO2 ratio is a noninvasive indicator of lung function and oxygenation efficiency, calculated as the ratio between peripheral oxygen saturation (SpO2, expressed as a percentage) and the fraction of inspired oxygen (FiO2, expressed as a fraction ranging from 0.21 to 1.00). This endpoint assesses the change from baseline in the SpO2/FiO2 ratio at predefined timepoints during the study.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Only those participants with data available at specified timepoints have been presented.

Posted

Mean

Standard Deviation

ratio (SpO2 [%] / FiO2 [fraction])

Days 3, 7, 14, 21, and 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

All-cause Mortality

Results for all-cause mortality rates in the FAS are reported, at day 28, day 60, and day 90. Analysis was based on logistic regression model with Multiple Imputation using retrieve dropouts with proportion of patients died up to Day 28 as dependent variable, treatment, disease severity at baseline (NIAID-OS <=5 vs. NIAID-OS 6), age class (<65, >= 65 years), sex and presence of concomitant disease at baseline as qualitative independent variables.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. These are also the numbers of patients considered in the model.

Posted

Number

95% Confidence Interval

% participants

Days 28, 60 and 90

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Hospital Re-admission by Day 90 and 180

Hospital Re-admission by Day 90 and 180 in the FAS is presented. The number of participants is expressed as unadjusted proportion.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 298 had available endpoint data by day 90, and 209 had available endpoint data by day 180.

Posted

Count of Participants

Participants

Days 90 and 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Time to Discharge or to a NEWS (National Early Warning Score) of ≤ 2 (for 24 Hours), Whichever Occurs First

The median time to discharge or to a NEWS (National Early Warning Score) of ≤ 2 (for 24 hours), whichever occurs first, was expressed using a "time to event" approach, and measured in days.

NIAID-OS, National Early Warning Score (NEWS) was evaluated daily until day 28 (or hospital discharge). In a scored system standardizing the assessment of acute-illness severity in the NHS, NEWS includes Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR), body temperature, level of consciousness (A, V, P, U), peripheral arterial oxygen saturation (SpO2) and supplemental oxygen.

Time to discharge or to a NEWS of <= 2 (for 24 hours) = Min(Date of discharge, Date of NEWS of <= 2 (for 24 hours)) - Day 1 date + 1.

Date of NEWS of <= 2 (for 24 hours): Given two consecutive days with NEWS of <= 2, the date of the first assessment has been considered.

Posted

Median

95% Confidence Interval

days

Day 28

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180

The EQ-5D-5L asks patients to indicate whether they have no, slight, moderate, severe, extreme problems on each of 5 dimensions of health: mobility; self-care; usual activities; pain/discomfort; anxiety/depression.The count of patients of each level (1 - no problems, 2 - slight problems, 3 - moderate problems, 4 - severe problems, 5 - extreme problems) for each of the 5 dimensions were reported. The higher the score for each dimension (range 1-5), the worse the outcome.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data.

n=120, n=108 for mobility & self care at Day 90 n=71, n= 81 for mobility, self care & usual activities at Day 180 n=120, n=108 for mobility and self care at Day 90 n=120, n=107 for usual activities at Day 90

Posted

Count of Participants

Participants

Days 90±7 and 180±14

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Duration of IMV and/or ECMO by Days 90 and 180

The summary of IMV/ECMO duration by day 90 and day 180 for the FAS is presented. The duration of IMV/ECMO use by day 90 was calculated as the total number of days between day 1 and the last available assessment day (≥ day 83) during which the participant was either receiving IMV/ECMO or had a NIAID-OS score of 7. Participants with less than 83 days of follow-up were considered non-evaluable for this endpoint.

Similarly, the duration of IMV/ECMO by day 180 was calculated using the same methodology.

Posted

Mean

Standard Deviation

Days

Days 90 and 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Proportion of Participants Requiring ICU Admission by Days 90 and 180

Unadjusted proportion of ICU admission is reported as number and percentage of participants requiring ICU admission by day 90 and day 180.

FAS: All randomized patients who received at least one dose of the investigational product. FAS set was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 302 had available data for this outcome by day 90 (n=157 in the reparixin arm and n=145 in the placebo arm) and 206 (n=106 in the reparixin arm and n=100 in the placebo arm) by day 180.

Posted

Count of Participants

Participants

Days 90 and 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care

Secondary

ICU Length of Stay by Days 90 and 180

Results for the Intensive Care Unit length of stay (days) by day 90 and day 180 in the FAS are reported.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS: 287 (n=147 in the rep arm and n=140 in the placebo arm) had available data for this outcome by day 90 and 180 (n=89 in the rep arm and n=91 for placebo) by day 180.

Posted

Mean

Standard Deviation

Days

Days 90 and 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Hospital Length of Stay by Days 90 and 180

Results for hospital length of stay (days) by day 90 and 180 in the FAS are reported.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS: 287 (147 R + 140 P) had available data for this outcome by day 90 and 180 (89 R + 91 P) by day 180.

Posted

Mean

Standard Deviation

Days

Days 90 and 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Occurrence of Infections by Days 90 and 180

Occurrence of infections was expressed as the unadjusted proportion of participants with at least one infection by days 90 and 180 in the FAS.

FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS: 299 (154 R + 145 P) had available data for this outcome by day 90 and 204 (101 R + 103 P) by day 180.

Posted

Count of Participants

Participants

Days 90 and 180

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
OG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Secondary

Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)

A TEAE is defined as any adverse event reported in the study having a possible, probable, or highly probable relationship to investigational product. A serious AE is defined as any untoward medical occurrence that at any dose:

results in death.
is life-threatening (i.e. the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe),
requires inpatient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity,
is a congenital anomaly/birth defect
is a medically significant or important medical condition, i.e. an important medical event that based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.

SAF: All randomized patients who received at least one dose of the investigational product. Please note that participants were summarized NOT according to their planned (randomized) treatment group, as reported in the Participant Flow subsection, BUT according to the actual treatment received. Hence n=200 for REP and n=194 for placebo.

Posted

Count of Participants

Participants

Throughout the study till Day 180 (± 14) or end of treatment

ID	Title	Description
OG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Reparixin + Standard of Care	Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days. The three daily doses were administered maintaining an interval between doses of about 8 hours. Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, if the patient was unable to eat, the study drug might be administered without concomitant food ingestion.	16	205	46	200	129	200
EG001	Placebo + Standard of Care	Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule. Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, if the patient was unable to eat, the placebo might still be administered without concomitant food ingestion.	19	204	56	194	127	194

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00011 events10 affected200 at risk EG00111 events11 affected194 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected200 at risk EG00110 events9 affected194 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 events8 affected200 at risk EG0015 events5 affected194 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 events6 affected200 at risk EG0015 events4 affected194 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0014 events4 affected194 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Influenza	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
COVID-19	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pneumocystis jirovecii pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pneumonia streptococcal	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pneumonia viral	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Myocarditis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cor pulmonale	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Osteomyelitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Dengue fever	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Renal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0013 events3 affected194 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected194 at risk
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0010 events0 affected194 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Sudden death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haematological malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Cerebrovascular accident	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Embolic stroke	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Syncope	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Diabetic neuropathy	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Myoclonus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Status migrainosus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Delirium	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Mania	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Mental status changes	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Adrenal haemorrhage	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Diabetic foot	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00013 events11 affected200 at risk EG00114 events14 affected194 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00010 events10 affected200 at risk EG0016 events6 affected194 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected200 at risk EG00111 events9 affected194 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 events6 affected200 at risk EG0016 events5 affected194 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0017 events7 affected194 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0015 events5 affected194 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected200 at risk EG0012 events2 affected194 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0014 events4 affected194 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0013 events3 affected194 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0013 events2 affected194 at risk
COVID-19	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0013 events2 affected194 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events2 affected194 at risk
Influenza	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0010 events0 affected194 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 events1 affected200 at risk EG0011 events1 affected194 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Pneumonia streptococcal	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hypocapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Infectious pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Lung abscess	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Musculoskeletal chest pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pharyngitis streptococcal	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pneumocystis jirovecii pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pneumonia viral	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pulmonary pneumatocele	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Rhinitis atrophic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00016 events15 affected200 at risk EG00112 events11 affected194 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00011 events11 affected200 at risk EG0018 events8 affected194 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected200 at risk EG0018 events7 affected194 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0018 events8 affected194 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0012 events2 affected194 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Chapped lips	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Oral pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Oropharyngeal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ulcerative duodenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00015 events15 affected200 at risk EG00114 events14 affected194 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0018 events7 affected194 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0013 events3 affected194 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events2 affected194 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected194 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Diabetic neuropathy	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hyperferritinaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hypouricaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Magnesium deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hepatic enzyme increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected200 at risk EG0014 events4 affected194 at risk
Transaminases increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0016 events6 affected194 at risk
C-reactive protein increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0015 events5 affected194 at risk
Fibrin D dimer increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0013 events3 affected194 at risk
Serum ferritin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0013 events3 affected194 at risk
Procalcitonin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events2 affected194 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0013 events3 affected194 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0013 events3 affected194 at risk
Liver function test increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Neutrophil count increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0013 events3 affected194 at risk
Platelet count increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
White blood cell count increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected194 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events1 affected194 at risk
Haematocrit decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
N-terminal prohormone brain natriuretic peptide increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Amylase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Anion gap increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Blood albumin decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Blood ketone body	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Blood pressure systolic abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Blood pressure systolic increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Electrocardiogram abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Eosinophil count increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Haematocrit increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haemoglobin decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lymphocyte count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
PaO2/FiO2 ratio	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Red blood cell count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Red blood cell count increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Troponin T	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Venous pressure jugular	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
White blood cell count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Atrial fibrillation	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected200 at risk EG0013 events3 affected194 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0014 events4 affected194 at risk
Tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0011 events1 affected194 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0010 events0 affected194 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Myocarditis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Bundle branch block left	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cor pulmonale	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Long QT syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Palpitations	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0016 events6 affected194 at risk
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0010 events0 affected194 at risk
Oral candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0011 events1 affected194 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0011 events1 affected194 at risk
Candida infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Dengue fever	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Osteomyelitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Aspergilloma	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Aspergillus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected200 at risk EG0010 events0 affected194 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Herpes simplex	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Herpes zoster	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lice infestation	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Meningitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Oral herpes	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Oropharyngitis fungal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pneumococcal bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pyuria	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Renal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Tinea pedis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Vulvovaginitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00010 events10 affected200 at risk EG0017 events7 affected194 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00011 events11 affected200 at risk EG0014 events4 affected194 at risk
Syncope	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events2 affected194 at risk
Phlebitis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected194 at risk
Aortic aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events1 affected194 at risk
Arteriosclerosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Carotid artery occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cerebrovascular accident	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Embolic stroke	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haemorrhoids thrombosed	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hypertensive urgency	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Peripheral venous disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Splenic infarction	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Carotid artery stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected200 at risk EG0015 events5 affected194 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0013 events3 affected194 at risk
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0013 events2 affected194 at risk
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0010 events0 affected194 at risk
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0011 events1 affected194 at risk
Chest discomfort	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Drug withdrawal syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Inflammation	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Influenza like illness	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Infusion site swelling	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Malaise	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Sudden death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0008 events7 affected200 at risk EG0015 events5 affected194 at risk
Tremor	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0012 events2 affected194 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Disturbance in attention	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events1 affected194 at risk
Encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hemiparesis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Migraine	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Myoclonus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Neuralgia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected200 at risk EG0010 events0 affected194 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Status migrainosus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Insomnia	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected200 at risk EG0013 events2 affected194 at risk
Anxiety	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0010 events0 affected194 at risk
Delirium	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0012 events1 affected194 at risk
Sleep disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected200 at risk EG0012 events2 affected194 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Mental status changes	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Confusional state	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Mania	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Restlessness	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Tobacco withdrawal symptoms	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0003 events2 affected200 at risk EG0015 events5 affected194 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0004 events3 affected200 at risk EG0014 events4 affected194 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0011 events1 affected194 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG00010 events9 affected200 at risk EG0011 events1 affected194 at risk
Renal failure	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected200 at risk EG0010 events0 affected194 at risk
Renal impairment	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Bladder pain	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Renal colic	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Urinary retention	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected200 at risk EG0012 events2 affected194 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events1 affected194 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Nail hypertrophy	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 events3 affected200 at risk EG0014 events4 affected194 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0013 events3 affected194 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected200 at risk EG0010 events0 affected194 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events2 affected194 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events1 affected194 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events1 affected194 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0012 events2 affected194 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected200 at risk EG0011 events1 affected194 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Penis injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Product administration error	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0011 events1 affected194 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Haematological malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0013 events3 affected194 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Deafness	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0012 events1 affected194 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Mitral valve repair	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Renal stone removal	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Therapy cessation	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Adrenal haemorrhage	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Blindness	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Cataract	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Visual impairment	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected200 at risk EG0011 events1 affected194 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected200 at risk EG0010 events0 affected194 at risk

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases