Prospective Study for the Use of Palivizumab (Synagis®) i... | NCT01155193

Prospective Study for the Use of Palivizumab (Synagis®) i... | NCT01155193 | Trialant

Description Module

Detailed Description

Each participant included in this study was observed during his/her palivizumab prophylaxis during the prevailing RSV season. According to the requirements for non-interventional or observational studies, no diagnostic or monitoring procedures were applied to the participants included in the study other than those which would ordinarily be applied in the course of the individual therapeutic strategy. Only data which were part of routine medical care were collected.

Data collection was conducted initially in season 2002/2003 using paper-based case report forms (CRFs); beginning in season 2008/2009 a protected internet-based data entry platform was used. Both the paper-based CRFs and the electronic system were subject to changes during the whole time of the registry.

Data collection for registry seasons 2002/2003 - 2006/2007 was conducted by use of paper-based CRFs and hospitalization forms. Corresponding results were published in 2011 and are hence depicted together and reported here as a separate reporting group.

Registry seasons 2007/2008 and 2008/2009 were considered transitional years in the process of switching the type of data collection to an electronic CRF (eCRF) system. Although data collection of registry 2007/2008 was still paper-based, it was not included in the original publication and hence, results are reported separately. In season 2008/2009 the mode of data collection was switched from paper-based CRFs to an eCRF system, however, several physicians still used the paper-based CRFs for documentation. In order to use all documentations and lose as few data as possible, results for 2008/2009 are based on a combination of paper-based CRF and eCRF data. Hence, it was decided to keep the results for 08/09 separate from the depiction of the homogenous, eCRF-based results of the following seasons.

Data collection for registry 09/10 - 15/16 was implemented by an eCRF system. Corresponding results are therefore depicted together in one reporting group.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palivizumab		Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season.

Outcomes Module

Measure	Description	Time Frame
Percentage of Participants With RSV-associated Hospitalization		During RSV season (September to June) from 2002 to 2016

Secondary Outcomes

Measure	Description	Time Frame
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08	Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.	During RSV season (September to June) from 2002 to 2008

Name	Affiliation	Role
Sandra Bloch, MD	AbbVie Deutschland GmbH & Co. KG, Medical Department	Study Director

Label	URL
Related Info	View source

Arm/Group Information

ID	Title	Description
FG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 until 30 June 2007.
FG001	Palivizumab Registry 07/08	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
FG002	Palivizumab Registry 08/09	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
FG003	Palivizumab Registry 09/10 - 15/16	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00010924 subjects FG0013818 subjects FG0022260 subjects FG00313802 subjects
COMPLETED		FG00010686 subjectsEvaluable population (participants treated between 01 September and 01 May of the following year) FG0013805 subjectsEvaluable population (participants treated between 01 September and 01 May of the following year) FG0022248 subjectsEvaluable population (participants treated between 01 September and 01 May of the following year) FG003
NOT COMPLETED		FG000238 subjects FG00113 subjects FG00212 subjects FG00391 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
BG001

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized	Gestational age at birth is reported

Outcome Measures Module

Outcome Measures

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

Percentage of Participants With RSV-associated Hospitalization

Evaluable population with available hospitalization data

Posted

Number

percentage of participants

During RSV season (September to June) from 2002 to 2016

ID	Title	Description
OG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
OG001	Palivizumab Registry 07/08	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.

Adverse Events Module

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	Palivizumab	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season (September to June) from 2002 to 2016.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Global Medical Services	AbbVie (prior sponsor, Abbott)	800-633-9110

Condition Browse Module

ID	Term
D018357	Respiratory Syncytial Virus Infections
D006330	Heart Defects, Congenital
D007239	Infections
D001997	Bronchopulmonary Dysplasia

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

Sex/Gender, Customized

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00312729
- ParticipantsBG00429468

Title	Measurements
Female	BG0004901 BG0011737 BG0021019 BG003

Birth Weight

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00312729
- ParticipantsBG00429468

Title	Measurements
< 1000 g	BG0003283 BG0011101 BG002595 BG003

Age at Start of Immunoprophylaxis

Data are reported where available. Data are reported separately for different registry phases as no overall analysis was performed.

Mean

Standard Deviation

months

Title

Denominators

Categories

Registry 02/03 - 06/07

- ParticipantsBG00010059
- ParticipantsBG0010
- ParticipantsBG0020
- ParticipantsBG0030
- ParticipantsBG00410059

Title	Measurements
	BG0005.2± 4.0 BG0045.2± 4.0

Registry 07/08

- ParticipantsBG0000
- ParticipantsBG0013578
- ParticipantsBG0020
- ParticipantsBG0030

Registry 08/09

- ParticipantsBG0000
- ParticipantsBG0010
- ParticipantsBG0022248
- ParticipantsBG0030

Registry 09/10 - 15/16

- ParticipantsBG0000
- ParticipantsBG0010
- ParticipantsBG0020
- ParticipantsBG00312729

Risk Factors for RSV Complications

Data are reported where available

Count of Participants

Participants

Title

Denominators

Categories

Premature birth (< 29 weeks GA)

- ParticipantsBG0008948
- ParticipantsBG0013076
- ParticipantsBG0022248
- ParticipantsBG00312729
- ParticipantsBG00427001

Title	Measurements
	BG0003582 BG0011173 BG002694 BG003

Premature birth (≤ 35 weeks GA)

- ParticipantsBG0008948
- ParticipantsBG0013076
- ParticipantsBG0022248
- ParticipantsBG00312729

Multiple births

- ParticipantsBG0009752
- ParticipantsBG0013771
- ParticipantsBG0022141
- ParticipantsBG00312147

Congenital heart disease

- ParticipantsBG0009588
- ParticipantsBG0013677
- ParticipantsBG0022248
- ParticipantsBG00312544

Smoking in the family

- ParticipantsBG0008043
- ParticipantsBG0013031
- ParticipantsBG0022248
- ParticipantsBG0036332

Chronic lung disease

- ParticipantsBG0009805
- ParticipantsBG0013501
- ParticipantsBG0022248
- ParticipantsBG00312422

Immunodeficiency

- ParticipantsBG0008875
- ParticipantsBG0013428
- ParticipantsBG0022248
- ParticipantsBG00312271

Attending daycare

- ParticipantsBG0009722
- ParticipantsBG0013745
- ParticipantsBG0022248
- ParticipantsBG00312389

Other children (< 12 years) in household

- ParticipantsBG0009662
- ParticipantsBG0013728
- ParticipantsBG0022248
- ParticipantsBG00310767

Family history of asthma

- ParticipantsBG0007877
- ParticipantsBG0012956
- ParticipantsBG0022248
- ParticipantsBG00310589

Family history of allergic rhinitis

- ParticipantsBG0007819
- ParticipantsBG0012920
- ParticipantsBG0022248
- ParticipantsBG00312729

Family history of allergic eczema

- ParticipantsBG0007751
- ParticipantsBG0012889
- ParticipantsBG0022248
- ParticipantsBG00312729

Family history of atopy

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00310606

Cyanotic heart defect

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00312363

Chronic lung disease therapy

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00312291

Treatment with oxygen at home

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00312490

Neuromuscular impairment

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG0038435

Down syndrome (Trisomy 21)

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00312729

Serious neurological disease

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG0038393

Low social status

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00311915

Crowded living conditions

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00310575

Exposition to air pollution

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00310960

Breast feeding ≤ 2 months

- ParticipantsBG00010686
- ParticipantsBG0013805
- ParticipantsBG0022248
- ParticipantsBG00311417

Immunoprophylaxis with Palivizumab Started in Hospital

Data are reported where available

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00010544
- ParticipantsBG0013745
- ParticipantsBG0021798
- ParticipantsBG00312729
- ParticipantsBG00428816

Title	Measurements
	BG0001645 BG001519 BG002313 BG003

Secondary

Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08

Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.

Participants in registries 02/03 - 06/07 and 07/08 who were hospitalized, and hospitalization was documented on paper case report forms.

Posted

Count of Units

hospitalizations

During RSV season (September to June) from 2002 to 2008

hospitalizations

ID	Title	Description
OG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
OG001	Palivizumab Registry 07/08	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.

Units	Counts
Participants	OG000324 OG001107
hospitalizations	OG000334 OG001

Title

Denominators

Categories

Bronchiolitis

Title	Measurements
	OG00067 OG00118

RSV-Bronchiolitis

Title	Measurements
	OG000

Secondary

Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16

In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge.

Participants in registries 08/09 and 09/10 - 15/16 who were hospitalized, and hospitalization was documented on forms and with available diagnosis data (for registry 09/10 - 15/16)

Posted

Count of Units

hospitalizations

During RSV season (September to June) from 2008 to 2016

hospitalizations

ID	Title	Description
OG000	Palivizumab Registry 08/09	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
OG001	Registry 09/10 - 15/16 Hospitalization Associated With RSV	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization associated with RSV infection.
OG002	Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.

Units	Counts
Participants	OG00079 OG00187 OG002269
hospitalizations	OG000

Title

Denominators

Categories

Bronchitis

Title	Measurements
	OG00024 OG00124 OG002115

Bronchiolitis

Secondary

Presence of Complications During Hospitalization

Evaluable population who were hospitalized and with available hospitalization complication data

Posted

Count of Units

hospitalizations

During RSV season (September to June) from 2002 to 2016

hospitalizations

ID	Title	Description
OG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 until 30 June 2007.
OG001	Palivizumab Registry 07/08	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
OG002	Palivizumab Registry 08/09	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
OG003	Registry 09/10 - 15/16 Hospitalization Associated With RSV	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was associated with RSV infection.
OG004	Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.

Units	Counts
Participants	OG000324 OG001107 OG00279 OG003

Title	Denominators	Categories
Intensive care unit (ICU) admission	ParticipantsOG000324 ParticipantsOG001107 ParticipantsOG00279 ParticipantsOG003

Secondary

Parental Cooperation in Registries 02/03 - 06/07 and 07/08

Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.

Evaluable population in registries 02/03 - 06/07 and 07/08

Posted

Count of Participants

Participants

During RSV season (September to June) from 2002 to 2008

ID	Title	Description
OG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
OG001	Palivizumab Registry 07/08	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.

Units	Counts
Participants	OG00010686 OG0013805

Title

Denominators

Categories

Title	Measurements
Very good/good	OG0009383 OG0013340
Moderate	OG000

Secondary

Parental Cooperation for Registry 08/09 and 09/10 - 15/16

Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad:

Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents.

Evaluable population in in registries 08/09 and 09/10 - 15/16; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.

Posted

Count of Units

Palivizumab injections

During RSV season (September to June) from 2008 to 2016

Palivizumab injections

ID	Title	Description
OG000	Palivizumab Registry 08/09	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
OG001	Palivizumab Registry 09/10 - 15/16	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.

Units	Counts
Participants	OG0002248 OG00112729
Palivizumab injections	OG00011039 OG001

Title

Denominators

Categories

Title	Measurements
Good	OG0008175 OG00151408
Satisfying	OG000

Secondary

Mean Number of Palivizumab Injections

The mean number of palivizumab injections per participant, per season.

Evaluable population; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.

Posted

Mean

Standard Deviation

palivizumab injections

During RSV season (September to June) from 2002 to 2016

ID	Title	Description
OG000	Palivizumab Registry 02/03 - 06/07	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.
OG001	Palivizumab Registry 07/08	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
OG002	Palivizumab Registry 08/09	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.
OG003	Palivizumab Registry 09/10 - 15/16	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.

Units	Counts
Participants	OG00010686 OG0013805 OG0022248 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004.7± 1.8 OG0014.8± 1.9 OG0024.9± 2.0 OG003

Title	Measurements
	BG0001234 BG001450 BG002NAThis risk factor was not assessed during this period BG003NAThis risk factor was not assessed during this period BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000713 BG001245 BG002NAThis risk factor was not assessed during this period BG003NAThis risk factor was not assessed during this period BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002346 BG0032039 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002123 BG003784 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002281 BG0031803 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002133 BG003763 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002120 BG003786 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002NAThis risk factor was not assessed during this period BG003249 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002NAThis risk factor was not assessed during this period BG003428 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002NAThis risk factor was not assessed during this period BG0032258 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002NAThis risk factor was not assessed during this period BG0032592 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002NAThis risk factor was not assessed during this period BG0031710 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Title	Measurements
	BG000NAThis risk factor was not assessed during this period BG001NAThis risk factor was not assessed during this period BG002NAThis risk factor was not assessed during this period BG0035794 BG004NATotal not calculated because data are not available (NA) in one or more arms.

Oxygen supplementation required

- ParticipantsOG000324
- ParticipantsOG001107
- ParticipantsOG00279
- ParticipantsOG00387
- ParticipantsOG004265
- hospitalizationsOG000334
- hospitalizationsOG001121
- hospitalizationsOG00290
- hospitalizationsOG00392
- hospitalizationsOG004

Title	Measurements
	OG000177 OG00154 OG00242 OG003

Mechanical ventilation

- ParticipantsOG000324
- ParticipantsOG001107
- ParticipantsOG00279
- ParticipantsOG00372
- ParticipantsOG004213
- hospitalizationsOG000334
- hospitalizationsOG001121
- hospitalizationsOG00290
- hospitalizationsOG00375
- hospitalizationsOG004

Title	Measurements
	OG00044 OG00111 OG0028 OG003