A Study of Safety and Efficacy of MK-1986 (Tedizolid Phos... | NCT03176134

NCT03176134

ID	Type	Description	Link
MK-1986-018	Other Identifier	MSD Protocol Number
2016-003884-20	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Tedizolid phosphate 6 to <12 Years	Experimental	Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.	Drug: Tedizolid phosphate
Cohort 1: Comparator 6 to <12 Years	Active Comparator	Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.	Drug: Comparator
Cohort 2: Tedizolid phosphate 2 to <6 Years	Experimental	Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.	Drug: Tedizolid phosphate
Cohort 2: Comparator 2 to <6 Years	Active Comparator	Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.	Drug: Comparator
Cohort 3: Tedizolid phosphate 28 Days to <2 Years	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tedizolid phosphate	Drug	Tedizolid phosphate IV solution or oral suspension	Cohort 1: Tedizolid phosphate 6 to <12 Years Cohort 2: Tedizolid phosphate 2 to <6 Years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced an Adverse Event (AE)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.	Up to approximately 35 days
Number of Participants Who Discontinued Study Treatment Due to an AE	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. The number of participants who discontinued study treatment due to an AE were reported.	Up to approximately day 15
Number of Participants With Hematopoietic Cytopenias	Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.	Up to approximately 35 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment	CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs & symptoms, absence/near resolution of regional/systemic signs of infection if present at baseline (BL) & no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event (TEAE) leading to study drug discontinuation & required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 & 3 & all cohorts together were reported, & failure & indeterminate responses were pooled.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a parent/legally acceptable representative who is able to give documented informed consent
Has acute bacterial skin and skin structure infections (ABSSSI), defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
Local symptoms of ABSSSI that started within 14 days before study start
Suspected or documented Gram-positive bacterial infection

Exclusion Criteria:

Uncomplicated skin and skin structure infection
ABSSSI due to or associated with disallowed etiology per protocol
Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) <48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy
Known bacteremia, severe sepsis, or septic shock
Significant or life-threatening condition, disease, or organ system condition
Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens
Received or is receiving treatment for active tuberculosis within 1 month of study start
Known or suspected severe neutropenia
Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count <15% (HIV testing is not required for eligibility)
Renal impairment that requires renal filtration
Severe hepatic impairment
Cardiac or electrocardiogram (ECG) finding that would limit participation in the study
Received an investigational medicinal product (not approved) within 30 days before study start
Investigational device present or removed within 30 days before study start
Previously treated with tedizolid phosphate
Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation
Contraindication, including hypersensitivity to all available comparator drugs
Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required
Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the end of treatment (EOT) visit, is allowed, as is administration during treatment with IV drug)
Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent
Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans)
Identified as having used illicit drugs (urine drug screening not required for entry)

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Rady Children's Hospital-San Diego ( Site 0118)		San Diego	California	92123	United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40233296	Result	Mngqibisa R, Fofanov O, Grazioso CF, Melgar Toledo M, Boddicker M, Broyde N, Koseoglu S, Romero L, Stevens M, Sears P. A Phase 3 Study of the Safety and Efficacy of Tedizolid Phosphate in Patients <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections. Pediatr Infect Dis J. 2025 Jun 1;44(6):533-538. doi: 10.1097/INF.0000000000004807. Epub 2025 Apr 14.

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 27, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

Cohort 3: Tedizolid phosphate 28 Days to <2 Years

Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates

All randomized participants.

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
BG001	Cohort 1: Comparator 6 to <12 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
BG002	Cohort 2: Tedizolid Phosphate 2 to <6 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
BG003	Cohort 2: Comparator 2 to <6 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
BG004	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
BG005	Cohort 3: Comparator 28 Days to <2 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0008.5± 1.7 BG0019.2± 1.4 BG0023.1± 1.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG0018 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Number of Participants Who Experienced an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.

All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to <28 Days Neonates) and Cohort 4: Comparator (Birth to <28 Days Term & preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.

Posted

Count of Participants

Participants

Up to approximately 35 days

ID	Title	Description
OG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
OG001	Cohort 1: Comparator 6 to <12 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
OG002	Cohort 2: Tedizolid Phosphate 2 to <6 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
OG003	Cohort 2: Comparator 2 to <6 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
OG004	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
OG005	Cohort 3: Comparator 28 Days to <2 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

Units	Counts
Participants	OG00044 OG00115 OG00216 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007 OG0012 OG0027 OG003

Primary

Number of Participants Who Discontinued Study Treatment Due to an AE

Posted

Count of Participants

Participants

Up to approximately day 15

ID	Title	Description
OG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
OG001	Cohort 1: Comparator 6 to <12 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.

Primary

Number of Participants With Hematopoietic Cytopenias

Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.

Posted

Count of Participants

Participants

Up to approximately 35 days

ID	Title	Description
OG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
OG001	Cohort 1: Comparator 6 to <12 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.
OG002	Cohort 2: Tedizolid Phosphate 2 to <6 Years

Secondary

Percentage of Participants With Clinical Response (CR) Per Investigator Assessment

CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs & symptoms, absence/near resolution of regional/systemic signs of infection if present at baseline (BL) & no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event (TEAE) leading to study drug discontinuation & required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 & 3 & all cohorts together were reported, & failure & indeterminate responses were pooled.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 25 days

ID	Title	Description
OG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

Secondary

Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment

CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs & symptoms, absence/near resolution of regional/systemic signs of infection if present at BL & no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event leading to study drug discontinuation & required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 & 3 and all cohorts together were reported, & failure & indeterminate responses were pooled.

CE participants included all randomized participants who received at least one dose of study intervention, had a confirmed ABSSSI, had a suspected or documented gram+ infection from BL, received a sufficient course of therapy. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to <28 Days Neonates) and Cohort 4: Comparator (Birth to <28 Days Term & preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 25 days

ID	Title	Description
OG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: Tedizolid Phosphate 6 to <12 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.	44	44	4	44
EG001	Cohort 1: Comparator 6 to <12 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	15	15	2	15
EG002	Cohort 2: Tedizolid Phosphate 2 to <6 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.	16	16	7	16
EG003	Cohort 2: Comparator 2 to <6 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	5	5	2	5
EG004	Cohort 3: Tedizolid Phosphate 28 Days to <2 Years	Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.	15	15	7	15
EG005	Cohort 3: Comparator 28 Days to <2 Years	Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.	5	5	2	5

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG0030 events0 affected5 at risk EG0040 events0 affected15 at risk EG0050 events0 affected5 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected44 at risk EG0011 events1 affected15 at risk EG0021 events1 affected16 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Catheter site pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Infusion site extravasation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Folliculitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Impetigo	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Viral infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected15 at risk EG0020 events0 affected16 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
White blood cell count increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0020 events0 affected16 at risk EG003
Pallor	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0010 events0 affected15 at risk EG0021 events1 affected16 at risk EG003

ID	Term
C515040	tedizolid phosphate

EG0041 events1 affected15 at risk