Comparison of Intravenous and Subcutaneous Administration... | NCT00546871

Comparison of Intravenous and Subcutaneous Administration... | NCT00546871 | Trialant

Arms/Interventions Module

Name	Type	Description	Arm Group Labels	Other Names
Immune Globulin Intravenous (Human), 10%	Drug	Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage	Expressed as (AUC_SC/AUC_IV) * 100	Week 12 (IV) and week 32 or 33 (SC)
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.	Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC)	Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped	Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs	Throughout study (1 year and 9 months)
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.	Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs	Throughout study (1 year and 9 months)
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped

Secondary Outcomes

Measure	Description	Time Frame
Study Part 1 (IV): Maximum Plasma Concentration (C-max)	Maximal immune globulin concentration after infusion	Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.
Study Part 1 (IV): Minimum Plasma Concentration (C-min)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
Diagnosis of a PID disorder as defined by World Health Organization criteria (IUIS Scientific Committee, Primary immunodeficiency diseases. Report of an IUIS Scientific Committee. Clin Exp Immunol. 1999) for which the subject has been receiving a regular regimen of IV immunoglobulin infusions every 21 ± 3 days or 28 ± 3 days or a regular SC immunoglobulin treatment at 1 to 2 week intervals over a period of at least 3 months pre-study at a dose of 300-800 mg/kg BW/4 weeks
Subjects are aged 2 years or older
Subjects have a serum trough level of IgG > 4.5 g/L at the last documented determination
A negative serum pregnancy test for any female subject who is of childbearing potential
Female subjects of childbearing potential agree to practice birth control measures for the duration of the study

Exclusion Criteria:

Subjects positive at enrollment for one or more of the following: Hepatitis B surface antigen (HBsAg), PCR for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1
Subjects with levels of alanine amino transferase (ALT) or aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory
Subjects with neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3)
Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender
Subjects with a malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)
Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease)
Subjects with anemia that would preclude phlebotomy for laboratory studies
Subjects who received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to study enrollment
Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin and/or ISG infusions
Subjects with IgA deficiency and known anti IgA antibodies
Subjects receiving antibiotic therapy for the treatment of infection within 7 days prior to enrollment
Subjects participating in another clinical study involving an investigational product or device within 28 days prior to study enrollment
Subjects with bleeding disorders or who are on anti-coagulation therapy

Contacts/Locations Module

Name	Affiliation	Role
Study Director	Takeda	Study Director

References Module

Citations

PubMed Identifier	Type	Citation
9440877	Background	Neu AM, Warady BA, Furth SL, Lederman HM, Fivush BA. Antibody levels to diphtheria, tetanus, and rubella in infants vaccinated while on PD: a Study of the Pediatric Peritoneal Dialysis Study Consortium. Adv Perit Dial. 1997;13:297-9.
	Result	Leibl H, Engl W, Melamed I, Stein M, Wasserman RL, Berger M, Schiff RI. IGIV-10% Infused Intravenously And Subcutaneously To Subjects With Primary Immunodeficiency Diseases - Comparison Of Pharmacokinetic Properties. Poster presentation at AAAAI 2009.
	Result	Schiff RI, Leibl H, Engl W. Pharmacokinetic properties of Gammagard Liquid 10% (KIOVIG) administered intravenously and subcutaneously to patients with primary immunodeficiency diseases. Clin Exp Immunol. 154 (Suppl. 1):132, 2008
21424824

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	2 to <12 Years	Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined "Adjusted Dose" in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Part 2 - Subcutaneous (SC) IGIV, PK

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00135 subjects
COMPLETED		FG00012 subjects FG00132 subjects
NOT COMPLETED		FG0001 subjects FG0013 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0012 subjects
Family Emergency		FG0000 subjects FG001

Study Extension Period

Type	Comment	Milestone Data
STARTED		FG00010 subjects2 withdrawn after Part 3b FG00126 subjects6 withdrawn after Part 3b
COMPLETED		FG0009 subjects FG00125 subjects
NOT COMPLETED		FG0001 subjects FG0011 subjects

Type	Comment	Reasons
Protocol Violation		FG0001 subjects FG0010 subjects
Withdrawal by Subject		FG0000 subjects FG001

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

2 to <12 years

Title	Measurements
	BG00014

≥ 12 years

Title	Measurements
	BG00035

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022
Male	BG00027

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00049

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

Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage

Expressed as (AUC_SC/AUC_IV) * 100

Participants, ≥12 years, with PK data in terms of AUC[0-τ]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b

Posted

Number

90% Confidence Interval

percent

Week 12 (IV) and week 32 or 33 (SC)

ID	Title	Description
OG000	Participants ≥12 Years Old With PK Data Part 1 and Part 3b	IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose

Units	Counts
Participants	OG00029

Title

Denominators

Categories

Title	Measurements
	OG00095.2(92.3 to 98.2)

Primary

Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.

Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC)

Full safety data set (all participants, aged 2 to <12 years who received any study drug)

Posted

Median

95% Confidence Interval

g/L

Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation

ID	Title	Description
OG000	Participants Aged 2 to <12 Years

Units	Counts
Participants	OG000

Secondary

Study Part 1 (IV): Maximum Plasma Concentration (C-max)

Maximal immune globulin concentration after infusion

Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)

Posted

Median

95% Confidence Interval

g/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Study Part 1 (IV): Minimum Plasma Concentration (C-min)

Minimal immune globulin concentration after infusion

Posted

Median

95% Confidence Interval

g/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Study Part 1 (IV): Weight-adjusted Clearance

Computed as weight-adjusted dose divided by total AUC

Posted

Median

95% Confidence Interval

mL/kg/day

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Study Part 1 (IV): Terminal Half-life

Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.

Posted

Median

95% Confidence Interval

days

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)

Maximal immune globulin concentration after infusion

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

g/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00031

Secondary

Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)

Time to reach C-max

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

days

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00031

Secondary

Study Part 2 (SC): Minimum Plasma Concentration (C-min)

Minimal immune globulin concentration after infusion

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

g/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00031

Secondary

Study Part 2 (SC): Weight-adjusted Clearance

Computed as weight-adjusted dose divided by total AUC

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

mL/kg/day

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00031

Secondary

Study Part 3B: Maximum Plasma Concentration (C-max)

Maximal immune globulin concentration after infusion

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

g/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00032

Secondary

Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)

Time to reach C-max

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

days

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00032

Secondary

Study Part 3B: Minimum Plasma Concentration (C-min)

Minimal immune globulin concentration after infusion

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

g/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00032

Secondary

Study Part 3B: Area Under the Curve (AUC)

The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

g*days/L

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Study Part 3B: Weight-adjusted Clearance

Computed as weight-adjusted dose divided by total AUC

Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Posted

Median

95% Confidence Interval

mL/kg/day

Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG00032

Secondary

Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older

Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks) Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks) Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks) Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)

Full safety data set (all participants who received any study drug), 12 Years and Older

Posted

Median

95% Confidence Interval

g/L

ID	Title	Description
OG000	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants

Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.

All participants with specific antibody test results

Posted

Median

95% Confidence Interval

µg/mL

Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation

ID	Title	Description
OG000	All Participants

Units	Counts
Participants	OG00049

Secondary

Trough Levels of Antibody to Hepatitis B in All Study Participants

Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.

All participants with specific antibody test results

Posted

Median

95% Confidence Interval

mIU/mL

ID	Title	Description
OG000	All Participants

Units	Counts
Participants	OG00049

Primary

Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Full safety data set (all participants who received any study drug)

Posted

Number

Percentage of Participants

Throughout study (1 year and 9 months)

ID	Title	Description
OG000	Infusion Rate Change - For Any Reason	Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
OG001	Infusion Rate Change - For Tolerability/AE	Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs

Units	Counts
Participants	OG000

Secondary

Trough Levels of Antibody to Tetanus In All Study Participants

Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.

All participants with specific antibody test results

Posted

Median

95% Confidence Interval

IU/mL

ID	Title	Description
OG000	All Participants

Units	Counts
Participants	OG00049

Secondary

Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level

Antibody Titers That Were Below or Above the Protective Titer Level of >1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.

All study participants

Posted

Number

Antibody titers

ID	Title	Description
OG000	Full Safety Data Set

Units	Counts
Participants	OG000

Secondary

Annual Infection Rates During Treatment

Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.

Full safety data set (all participants who received any study drug)

Posted

Mean

95% Confidence Interval

Estimated infections per year

Throughout the study, 1 year and 9 months

ID	Title	Description
OG000	2 to <12 Years
OG001	12 Years and Older

Units	Counts
Participants	OG000

Secondary

Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)

Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.

Full Safety Data Set (All study participants who received any infusions)

Posted

Number

Estimated infections/year

Throughout the study, 1 year and 9 months

ID	Title	Description
OG000	IV Treatment	Study Part 1
OG001	All SC Treatment Periods	Study Parts 2, 3a, 3b, extension

Units	Counts
Participants	OG000

Secondary

Rate of Temporally Associated AEs Per Infusion

Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") divided by the total number of infusions.

All participants who received any study drug

Posted

Number

AEs per infusion

During Infusion or Within 72 Hours of Completion of Infusions

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of subjects naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants

Secondary

AEs Deemed/Judged to be Related by the Investigator

Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.

All participants who received any study drug

Posted

Number

AEs per infusion

Throughout the study period (1 year and 9 months)

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants

Secondary

Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L)

Frequency of Dose Adjustments Based on IgG Trough Levels <4.5 g/L IgG, if Any, for Each Study Part. Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.

All participants who received any study drug

Posted

Number

ratio

Throughout the study period (1 year and 9 months)

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants

Secondary

Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs

Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.

All participants who received any study drug

Posted

Number

Proportion of participants

During Infusion or Within 72 Hours of Completion of Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants

Primary

Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.

SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)

Posted

Number

Percentage of Participants

Throughout study (1 year and 9 months)

ID	Title	Description
OG000	Infusion Rate Change - For Any Reason	Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
OG001	Infusion Rate Change - For Tolerability/AE	Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs

Units	Counts
Participants

Secondary

Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR

All study participants who received any study drug during each of the study parts

Posted

Number

Adverse events

Throughout entire study (1 year and 9 months)

ID	Title	Description
OG000	Study Part 1, IV Administration
OG001	Study Part 2, SC Administration
OG002	Study Part 3a, SC Administration
OG003	Study Part 3b, SC Administration
OG004	Study Extension, SC Administration
OG005	Total SC (Parts 2, 3a, 3b, Extension)

Secondary

Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.

All study participants who received any study drug during each of the study parts

Posted

Number

AEs per infusion

Throughout entire study (1 year and 9 months)

ID	Title	Description
OG000	Study Part 1, IV Administration
OG001	Study Part 2, SC Administration
OG002	Study Part 3a, SC Administration
OG003	Study Part 3b, SC Administration
OG004	Study Extension, SC Administration
OG005

Secondary

Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages)

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR

Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts

Posted

Number

Adverse events

Throughout entire study (1 year and 9 months)

ID	Title	Description
OG000	Study Part 1, IV Administration
OG001	Study Part 2, SC Administration
OG002	Study Part 3a, SC Administration
OG003	Study Part 3b, SC Administration
OG004	Study Extension, SC Administration
OG005	Total SC (Study Parts 2, 3a, 3b, Extension)

Secondary

Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages)

Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts

Posted

Number

AEs per infusion

Throughout entire study (1 year and 9 months)

ID	Title	Description
OG000	Study Part 1, IV Administration
OG001	Study Part 2, SC Administration
OG002	Study Part 3a, SC Administration
OG003	Study Part 3b, SC Administration
OG004	Study Extension, SC Administration

Secondary

Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR

All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts

Posted

Number

Adverse events

Throughout entire study (1 year and 9 months)

ID	Title	Description
OG000	Study Part 1, IV Administration
OG001	Study Part 2, SC Administration
OG002	Study Part 3a, SC Administration
OG003	Study Part 3b, SC Administration
OG004	Study Extension, SC Administration
OG005	Total SC (Parts 2, 3a, 3b, Extension)

Secondary

Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)

All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts

Posted

Number

AEs per infusion

Throughout entire study (1 year and 9 months)

ID	Title	Description
OG000	Study Part 1, IV Administration
OG001	Study Part 2, SC Administration
OG002	Study Part 3a, SC Administration
OG003	Study Part 3b, SC Administration
OG004	Study Extension, SC Administration

Secondary

Percentage of Infusions Associated With ≥1 AE Related to the Study Drug

All participants who received any study drug

Posted

Number

Percentage of infusions

Throughout the study period (1 year and 9 months)

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants	OG000

Secondary

Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion

All participants who received any study drug

Posted

Number

Percentage of infusions

During Infusion or Within 72 Hours of Completion of Infusions

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants	OG000

Secondary

Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.

All participants who received any study drug

Posted

Number

Percentage of infusions

During Infusion or Within 72 Hours of Completion of Infusions

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants	OG000

Secondary

Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.

All participants who received any study drug

Posted

Number

Percentage of infusions

During Infusion or Within 72 Hours of Completion of Infusions

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped

SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)

Posted

Number

Percentage of Participants

Throughout study (1 year and 9 months)

ID	Title	Description
OG000	Infusion Rate Change - For Any Reason	Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
OG001	Infusion Rate Change - For Tolerability/AE	Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs

Units	Counts
Participants

Primary

Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Full safety data set (all participants who received any study drug)

Posted

Number

95% Confidence Interval

Percentage of Infusions

Throughout study (1 year and 9 months)

Infusions

ID	Title	Description
OG000	Infusion Rate Change (Percentage) - For Any Reason	Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
OG001	Infusion Rate Change - For Tolerability/AE	Infusion Rate Reduced and/or Infusion Interrupted or Stopped

Units	Counts
Participants	OG000

Primary

Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped

SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)

Posted

Number

95% Confidence Interval

Percentage of Infusions

Throughout study (1 year and 9 months)

Infusions

ID	Title	Description
OG000	Infusion Rate Change (Percentage) - For Any Reason	Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
OG001	Infusion Rate Change - For Tolerability/AE	Infusion Rate Reduced and/or Infusion Interrupted or Stopped

Units	Counts
Participants

Primary

Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped

SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)

Posted

Number

95% Confidence Interval

Percentage of Infusions

Throughout study (1 year and 9 months)

Infusions

ID	Title	Description
OG000	Infusion Rate Change (Percentage) - For Any Reason	Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
OG001	Infusion Rate Change - For Tolerability/AE	Infusion Rate Reduced and/or Infusion Interrupted or Stopped

Units	Counts
Participants

Secondary

Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.

All participants who received any study drug

Posted

Number

Percentage of infusions

During Infusion or Within 72 Hours of Completion of Infusions

Infusions

ID	Title	Description
OG000	FSDS	All participants who received any study drug
OG001	SNSC	Dataset of participants naïve to SC administration of immunoglobulins
OG002	SESC	Dataset of participants with prior experience with subcutaneous administration of immunoglobulins

Units	Counts
Participants	OG000

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	IV Treatment Period	Study Part 1			2	49	38	49
EG001	SC Treatment Period	Study Parts 2, 3a, 3b, and Extension			2	48	44	47

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sinusitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected48 at risk
Convulsion/seizure	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected48 at risk
Biliary Tract Infection Bacterial	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected48 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected48 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0013 events3 affected47 at risk
EAR PAIN	Ear and labyrinth disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0015 events4 affected47 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0013 events3 affected47 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0013 events3 affected47 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (Unspecified)	EG0002 events1 affected49 at risk EG00112 events5 affected47 at risk
APHTHOUS STOMATITIS	Gastrointestinal disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0014 events3 affected47 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0014 events3 affected47 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (Unspecified)	EG0003 events3 affected49 at risk EG00113 events5 affected47 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (Unspecified)	EG0006 events5 affected49 at risk EG00122 events8 affected47 at risk
VOMITING	Gastrointestinal disorders	MedDRA (Unspecified)	EG00011 events7 affected49 at risk EG00112 events7 affected47 at risk
CHILLS	General disorders	MedDRA (Unspecified)	EG00013 events7 affected49 at risk EG0010 events0 affected47 at risk
FATIGUE	General disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG00111 events7 affected47 at risk
INFUSION SITE ERYTHEMA	General disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0013 events3 affected47 at risk
INFUSION SITE HAEMATOMA	General disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG00115 events5 affected47 at risk
INFUSION SITE OEDEMA	General disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0013 events3 affected47 at risk
INFUSION SITE PAIN	General disorders	MedDRA (Unspecified)	EG0002 events1 affected49 at risk EG00122 events10 affected47 at risk
INFUSION SITE RASH	General disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0014 events4 affected47 at risk
PYREXIA	General disorders	MedDRA (Unspecified)	EG0008 events5 affected49 at risk EG00122 events14 affected47 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0013 events3 affected47 at risk
BLOOD PRESSURE SYSTOLIC INCREASED	Investigations	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG00110 events3 affected47 at risk
HEART RATE INCREASED	Investigations	MedDRA (Unspecified)	EG0005 events4 affected49 at risk EG00113 events3 affected47 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG0002 events1 affected49 at risk EG0019 events3 affected47 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0014 events4 affected47 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0019 events4 affected47 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG0005 events3 affected49 at risk EG0013 events3 affected47 at risk
HEADACHE	Nervous system disorders	MedDRA (Unspecified)	EG00042 events17 affected49 at risk EG00142 events23 affected47 at risk
MIGRAINE	Nervous system disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0015 events4 affected47 at risk
SINUS HEADACHE	Nervous system disorders	MedDRA (Unspecified)	EG0003 events2 affected49 at risk EG0013 events3 affected47 at risk
INSOMNIA	Psychiatric disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0013 events3 affected47 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0003 events3 affected49 at risk EG0019 events6 affected47 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0013 events3 affected47 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0014 events3 affected47 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0002 events1 affected49 at risk EG0018 events6 affected47 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	EG0001 events1 affected49 at risk EG0014 events3 affected47 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	EG0000 events0 affected49 at risk EG0013 events3 affected47 at risk

Title

Denominators

Categories

Part 1 (IV), Screening visit (n=14)

Title	Measurements
	OG00011.400(9.640 to 16.800)

Part 1 (IV), 3 week Interval, Visit 1 (n=5)

Title	Measurements
	OG00010.100(NA to NA)Evaluable sample size was too small

Part 1 (IV), 3 week Interval, Visit 2 (n=4)

Title	Measurements
	OG00011.500(NA to NA)Evaluable sample size was too small

Part 1 (IV), 3 week Interval, Visit 3 (n=5)

Title	Measurements
	OG00010.600(NA to NA)Evaluable sample size was too small

Part 1 (IV), 3 week Interval, Visit 4 (n=5)

Title	Measurements
	OG00010.100(NA to NA)Evaluable sample size was too small

Part 1 (IV), 3 week Interval, Visit 5 (n=5)

Title	Measurements
	OG00010.800(NA to NA)Evaluable sample size was too small

Part 1 (IV), 4 week Interval, Visit 1 (n=7)

Title	Measurements
	OG0009.640(7.240 to 17.400)

Part 1 (IV), 4 week Interval, Visit 2 (n=9)

Title	Measurements
	OG00010.000(7.230 to 12.400)

Part 1 (IV), 4 week Interval, Visit 3 (n=7)

Title	Measurements
	OG0009.080(6.340 to 18.500)

Part 1 (IV), 4 week Interval, Visit 4 (n=8)

Title	Measurements
	OG00010.500(7.420 to 17.800)

Part 2 (SC), Visit 1 (n=12)

Title	Measurements
	OG00013.650(12.300 to 16.700)

Part 2 (SC), Visit 5 (n=12)

Title	Measurements
	OG00012.800(11.200 to 16.500)

Part 2 (SC), Visit 9 (n=12)

Title	Measurements
	OG00013.600(10.100 to 17.100)

Part 3a (SC), Visit 1 (n=11)

Title	Measurements
	OG00011.200(10.300 to 19.100)

Part 3a (SC), Visit 5 (n=11)

Title	Measurements
	OG00012.200(11.500 to 20.000)

Part 3b (SC), Visit 1 (n=12)

Title	Measurements
	OG00011.500(9.170 to 15.800)

Part 3b (SC), Visit 5 (n=12)

Title	Measurements
	OG00012.600(10.200 to 15.200)

Part 3b (SC), Visit 9 (n=12)

Title	Measurements
	OG00012.800(10.300 to 15.900)

End of Study (n=13)

Title	Measurements
	OG00012.300(8.570 to 18.000)

Title

Denominators

Categories

Part 1, Screening visit (n=35)

Title	Measurements
	OG00011.800(10.300 to 13.000)

Part 1, 3 week Interval, Visit 1 (n=4)

Title	Measurements
	OG00010.900(NA to NA)Evaluable sample size was too small

Part 1, 3 week Interval, Visit 2 (n=4)

Title	Measurements
	OG00011.050(NA to NA)Evaluable sample size was too small

Part 1, 3 week Interval, Visit 3 (n=5)

Title	Measurements
	OG00014.000(NA to NA)Evaluable sample size was too small

Part 1, 3 week Interval, Visit 4 (n=5)

Title	Measurements
	OG00011.700(NA to NA)Evaluable sample size was too small

Part 1, 3 week Interval, Visit 5 (n=5)

Title	Measurements
	OG00012.400(NA to NA)Evaluable sample size was too small

Part 1, 4 week Interval, Visit 1 (n=29)

Title	Measurements
	OG00011.000(10.000 to 12.300)

Part 1, 4 week Interval, Visit 2 (n=29)

Title	Measurements
	OG00010.800(9.650 to 12.500)

Part 1, 4 week Interval, Visit 3 (n=30)

Title	Measurements
	OG00010.200(9.480 to 12.600)

Part 1, 4 week Interval, Visit 4 (n=30)

Title	Measurements
	OG00010.150(9.480 to 12.200)

Part 2, Visit 1 (n=35)

Title	Measurements
	OG00015.300(14.800 to 17.100)

Part 2, Visit 5 (n=34)

Title	Measurements
	OG00012.700(11.600 to 15.200)

Part 2, Visit 9 (n=32)

Title	Measurements
	OG00012.900(11.800 to 14.800)

Part 3a, Visit 1 (n=32)

Title	Measurements
	OG00012.850(11.600 to 14.900)

Part 3a, Visit 5 (n=31)

Title	Measurements
	OG00013.100(11.400 to 15.100)

Part 3b, Visit 1 (n=31)

Title	Measurements
	OG00012.900(11.600 to 15.200)

Part 3b, Visit 5 (n=28)

Title	Measurements
	OG00013.400(11.000 to 14.600)

Part 3b, Visit 9 (n=31)

Title	Measurements
	OG00013.600(11.000 to 14.400)

End of Study (n=34)

Title	Measurements
	OG00013.100(11.300 to 14.400)

Title

Denominators

Categories

Part 1, Screening visit (n=49)

Title	Measurements
	OG0002.790(2.300 to 3.240)

Part 1, 3 week Interval, Visit 1 (n=10)

Title	Measurements
	OG0002.830(2.020 to 4.350)

Part 1, 3 week Interval, Visit 2 (n=10)

Title	Measurements
	OG0002.885(1.910 to 4.310)

Part 1, 3 week Interval, Visit 3 (n=10)

Title	Measurements
	OG0003.150(2.030 to 3.950)

Part 1, 3 week Interval, Visit 4 (n=10)

Title	Measurements
	OG0003.145(0.820 to 4.040)

Part 1, 3 week Interval, Visit 5 (n=10)

Title	Measurements
	OG0003.045(1.650 to 4.140)

Part 1, 4 week Interval, Visit 1 (n=38)

Title	Measurements
	OG0002.210(1.860 to 2.480)

Part 1, 4 week Interval, Visit 2 (n=39)

Title	Measurements
	OG0002.030(1.680 to 2.780)

Part 1, 4 week Interval, Visit 3 (n=39)

Title	Measurements
	OG0002.130(1.750 to 2.670)

Part 1, 4 week Interval, Visit 4 (n=38)

Title	Measurements
	OG0002.135(2.020 to 2.610)

Part 2, Visit 1 (n=47)

Title	Measurements
	OG0003.280(3.000 to 3.860)

Part 2, Visit 5 (n=46)

Title	Measurements
	OG0002.810(2.360 to 3.080)

Part 2, Visit 9 (n=44)

Title	Measurements
	OG0003.175(2.530 to 3.470)

Part 3a, Visit 1 (n=44)

Title	Measurements
	OG0002.840(2.400 to 3.160)

Part 3b, Visit 1 (n=43)

Title	Measurements
	OG0003.030(2.610 to 3.500)

Part 3b, Visit 5 (n=41)

Title	Measurements
	OG0003.070(2.820 to 3.650)

Part 3b, Visit 9 (n=44)

Title	Measurements
	OG0003.285(2.780 to 3.870)

Extension, Visit 1 (n=36)

Title	Measurements
	OG0002.940(2.530 to 3.780)

End of Study (n=46)

Title	Measurements
	OG0003.010(2.660 to 3.690)

Title

Denominators

Categories

Part 1, Screening visit (n=36)

Title	Measurements
	OG000239.450(180.000 to 293.300)

Part 1, 3 week Interval, Visit 1 (n=8)

Title	Measurements
	OG000182.050(139.500 to 789.000)

Part 1, 3 week Interval, Visit 2 (n=10)

Title	Measurements
	OG000251.150(208.600 to 311.900)

Part 1, 3 week Interval, Visit 3 (n=10)

Title	Measurements
	OG000282.050(231.900 to 333.900)

Part 1, 3 week Interval, Visit 4 (n=10)

Title	Measurements
	OG000274.200(223.100 to 460.700)

Part 1, 3 week Interval, Visit 5 (n=10)

Title	Measurements
	OG000261.850(233.900 to 292.400)

Part 1, 4 week Interval, Visit 1 (n=36)

Title	Measurements
	OG000197.750(135.600 to 242.200)

Part 1, 4 week Interval, Visit 2 (n=39)

Title	Measurements
	OG000213.600(191.000 to 282.500)

Part 1, 4 week Interval, Visit 3 (n=39)

Title	Measurements
	OG000202.800(172.200 to 262.600)

Part 1, 4 week Interval, Visit 4 (n=38)

Title	Measurements
	OG000207.850(183.800 to 265.800)

Part 2, Visit 1 (n=46)

Title	Measurements
	OG000401.350(380.800 to 482.200)

Part 2, Visit 5 (n=46)

Title	Measurements
	OG000341.100(301.700 to 364.700)

Part 2, Visit 9 (n=44)

Title	Measurements
	OG000316.800(282.800 to 367.900)

Part 3a, Visit 1 (n=44)

Title	Measurements
	OG000318.450(280.200 to 351.000)

Part 3b, Visit 1 (n=43)

Title	Measurements
	OG000385.200(304.300 to 454.300)

Part 3b, Visit 5 (n=41)

Title	Measurements
	OG000314.100(247.200 to 374.900)

Part 3b, Visit 9 (n=44)

Title	Measurements
	OG000351.050(292.000 to 412.200)

Extension, Visit 1 (n=36)

Title	Measurements
	OG000328.750(273.100 to 368.400)

End of Study (n=44)

Title	Measurements
	OG000319.600(297.000 to 372.400)

Title

Denominators

Categories

Study Part 1 (IV) (n= 49)

Title	Measurements
	OG00018.4 OG00116.3

Study Part 2 (SC) (n= 47)

Title	Measurements
	OG00029.8 OG0014.3

Study Part 3A (SC) (n=44)

Title	Measurements
	OG00015.9 OG0012.3

Study Part 3B (SC) (n=44)

Title	Measurements
	OG00013.6 OG0012.3

Study Extension (SC) (n= 36)

Title	Measurements
	OG00013.9 OG0010.0

Study Part 2, 3A, 3B, Study Extension (n= 47)

Title	Measurements
	OG00040.4 OG0014.3

Title

Denominators

Categories

Part 1, Screening visit (n=49)

Title	Measurements
	OG0002.840(2.500 to 3.660)

Part 1, 3 week Interval, Visit 1 (n=10)

Title	Measurements
	OG0003.010(1.740 to 3.640)

Part 1, 3 week Interval, Visit 2 (n=10)

Title	Measurements
	OG0003.500(1.970 to 4.640)

Part 1, 3 week Interval, Visit 3 (n=10)

Title	Measurements
	OG0003.360(2.180 to 4.540)

Part 1, 3 week Interval, Visit 4 (n=10)

Title	Measurements
	OG0003.205(1.810 to 5.030)

Part 1, 3 week Interval, Visit 5 (n=10)

Title	Measurements
	OG0003.520(2.230 to 4.220)

Part 1, 4 week Interval, Visit 1 (n=37)

Title	Measurements
	OG0002.340(1.980 to 2.830)

Part 1, 4 week Interval, Visit 2 (n=39)

Title	Measurements
	OG0002.360(1.880 to 2.760)

Part 1, 4 week Interval, Visit 3 (n=38)

Title	Measurements
	OG0002.125(1.890 to 2.680)

Part 1, 4 week Interval, Visit 4 (n=36)

Title	Measurements
	OG0002.325(1.910 to 2.800)

Part 2, Visit 1 (n=47)

Title	Measurements
	OG0004.310(3.890 to 5.050)

Part 2, Visit 5 (n=46)

Title	Measurements
	OG0003.445(2.920 to 4.030)

Part 2, Visit 9 (n=43)

Title	Measurements
	OG0003.720(3.090 to 4.160)

Part 3a, Visit 1 (n=44)

Title	Measurements
	OG0003.090(2.670 to 3.830)

Part 3b, Visit 1 (n=43)

Title	Measurements
	OG0003.690(3.210 to 4.220)

Part 3b, Visit 5 (n=41)

Title	Measurements
	OG0003.410(2.780 to 4.440)

Part 3b, Visit 9 (n=43)

Title	Measurements
	OG0003.150(2.920 to 3.920)

Extension, Visit 1 (n=36)

Title	Measurements
	OG0003.355(2.440 to 4.480)

End of Study (n=46)

Title	Measurements
	OG0003.860(3.150 to 5.000)

Title

Denominators

Categories

Study Part 1 (IV)

Title	Measurements
	OG0005.0(2.3 to 9.3) OG0015.2(3.6 to 7.2)

Study Part 2 (SC)

Title	Measurements
	OG0005.6(2.7 to 10.0) OG0014.1(2.6 to 6.1)

Study Part 3A (SC)

Title	Measurements
	OG0003.5(1.4 to 7.1) OG0014.6(2.6 to 7.3)

Study Part 3B (SC)

Title	Measurements
	OG0003.9(1.6 to 7.8) OG0013.8(2.4 to 5.8)

Study Extension (SC)

Title	Measurements
	OG0004.0(2.4 to 6.2) OG0013.8(2.6 to 5.3)

Study Part 2, 3A, 3B, Study Extension (all SC)

Title	Measurements
	OG0004.3(2.8 to 6.4) OG0014.0(3.0 to 5.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001						Poisson	0.067			1-Sided	99		0.134					Superiority or Other (legacy)

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG0000.25 OG0010.45 OG0020.00

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG0000.08 OG0010.13 OG0020.08

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0000.08 OG0010.08 OG0020.00

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0000.07 OG0010.09 OG0020.00

Total SC (N = 2294, 1757, 537)

Title	Measurements
	OG0000.08 OG0010.08 OG0020.00

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG0000.00 OG0010.25 OG0020.00

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG0000.07 OG0010.06 OG0020.08

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0000.00 OG0010.03 OG0020.00

Total SC (Study Parts 2, 3A, 3B, Study Extension)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Title

Denominators

Categories

Study Part 1 (IV)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Study Part 2 (SC)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Study Part 3a (SC)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Study Part 3b (SC)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Study Extension (SC)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Total SC (Study Parts 2, 3A, 3B, Study Extension)

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00

Title

Denominators

Categories

Study Part 1 (IV)

Title	Measurements
	OG0000.43 OG0010.47 OG0020.27

Study Part 2 (SC)

Title	Measurements
	OG0000.36 OG0010.44 OG0020.09

Study Part 3a (SC)

Title	Measurements
	OG0000.23 OG0010.24 OG0020.20

Study Part 3b (SC)

Title	Measurements
	OG0000.36 OG0010.38 OG0020.30

Study Extension (SC)

Title	Measurements
	OG0000.50 OG0010.56 OG0020.33

Total SC (Study Parts 2, 3A, 3B, Study Extension)

Title	Measurements
	OG0000.66 OG0010.75 OG0020.36

Title

Denominators

Categories

Study Part 1 (IV) (n= 38)

Title	Measurements
	OG00023.7 OG00121.1

Study Part 2 (SC) (n= 36)

Title	Measurements
	OG00033.3 OG0015.6

Study Part 3A (SC) (n=34)

Title	Measurements
	OG00020.6 OG0012.9

Study Part 3B (SC) (n=34)

Title	Measurements
	OG00017.6 OG0012.9

Study Extension (SC) (n= 27)

Title	Measurements
	OG00014.8 OG0010.0

Study Part 2, 3A, 3B, Study Extension (n= 36)

Title	Measurements
	OG00047.2 OG0015.6

Title

Denominators

Categories

Abdominal Discomfort- non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG0030 OG0043 OG0053

Abdominal Distension-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Distension-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Distension-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Abdominal Distension-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Abdominal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Abdominal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0013 OG0021 OG003

Abdominal Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Acne-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Acne-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Acute Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Addison's Disease-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Addison's Disease-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Alopecia-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Ammonia Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Animal Bite-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Anorexia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Anxiety-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Aphthous Stomatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Arthralgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0013 OG0021 OG003

Arthralgia-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Arthralgia-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Arthralgia-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Arthritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Arthropod Bite-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Asthenia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Asthma-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthma-non-SAE, NR, Moderate

Title	Measurements
	OG0003 OG0010 OG0021 OG003

Asthma-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Asthma Exercise Induced-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

ADHD-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Back Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Back Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Back Pain-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Biliary Tract Infection Bacterial-SAE, NR, Moderat

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Blepharitis-non-SAE,NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Blepharitis-non-SAE,NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

B.P. Diastolic Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0022 OG003

Blood Pressure Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Blood Pressure Increased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

B.P. Systolic Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

B.P. Systolic Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

B.P. Systolic Increased-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0014 OG0022 OG003

B.P. Systolic Increased-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Breast Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Breath Sounds Abnormal-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Bronchitis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Bronchitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Bursitis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Cardiac Murmur-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Centrl Venous Catheterisation-non-SAE, NR, Moderat

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Cervical Spinal Stenosis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chest Pain-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chills-non-SAE, R, Mild

Title	Measurements
	OG0007 OG0010 OG0020 OG003

Chills-non-SAE, R, Moderate

Title	Measurements
	OG0006 OG0010 OG0020 OG003

C.O.P.D.-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

C.O.P.D.-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Chronic Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Chronic Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Confusional State-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Conjunctival Hyperaemia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Conjunctivitis Allergic-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Conjunctivitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Conjunctivitis Infective-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Conjunctivitis Infective-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Constipation-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Constipation-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Contusion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Contusion-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Convulsion-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Convulsion-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Costochondritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Costochondritis-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Cough-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Cough-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Croup Infectious-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Croup Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Cryptosporidiosis Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Cystitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dental Caries-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dermatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dermatitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Dermatitis Contact-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0011 OG0021 OG003

Device Failure-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Diarrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Diarrhoea-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0012 OG0021 OG003

Diarrhoea-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0022 OG003

Diarrhoea Haemorrhagic-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Diarrhoea Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Diverticulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Drug Eruption-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Dyspepsia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Dyspnoea-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Dyspnoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dyspnoea-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Ear Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Ear Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0011 OG0021 OG003

Ear Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Eczema-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Eczema-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Epistaxis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Epistaxis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Excoriation-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Exostosis-non-SAE, NR,Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Eye Infection Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0003 OG0011 OG0020 OG003

Eye Irritation-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Eye Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Fall-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Fatigue-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Fatigue-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Fatigue-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0014 OG0020 OG003

Fatigue-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Flank Pain-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Flatulence-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Flatulence-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Folliculitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Fungal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Furuncle-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Gastric Ulcer-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Gastric Ulcer-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Gastroenteritis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Gastroenteritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Gastroenteritis-non-SAE, R, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Gastroenteritis Viral-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0012 OG0020 OG003

Gastroenteritis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Goitre-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Gravitational Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Haematochezia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Haemoglobin Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Haemorrhoids-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Head Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Headache-non-SAE, NR, Mild

Title	Measurements
	OG0008 OG0015 OG0023 OG003

Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0004 OG0010 OG0022 OG003

Headache-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Headache-non-SAE, R, Mild

Title	Measurements
	OG00019 OG0016 OG0021 OG003

Headache-non-SAE, R, Moderate

Title	Measurements
	OG0008 OG0011 OG0021 OG003

Headache-non-SAE, R, Severe

Title	Measurements
	OG0003 OG0011 OG0020 OG003

Heart Rate Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0023 OG003

Heart Rate Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Heart Rate Increased-non-SAE, R, Mild

Title	Measurements
	OG0004 OG0014 OG0023 OG003

Heart Rate Increased-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Hiatus Hernia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Hordeolum-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Hyperlipidaemia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Hypoxia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Implant Site Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infection-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0011 OG0021 OG003

Influenza-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0013 OG0020 OG003

Influenza-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0014 OG0020 OG003

Infusion Related Reaction-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Infusion Site Erythema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Infusion Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0022 OG003

Infusion Site Haematoma-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Haemorrhage-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Infusion Site Irritation-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Infusion Site Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Infusion Site Pain-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0019 OG0022 OG003

Infusion Site Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0015 OG0021 OG003

Infusion Site Pruritus-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Pruritus-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0021 OG003

Infusion Site Pruritus-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Rash-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Rash-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Infusion Site Reaction-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Swelling-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Swelling-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Infusion Site Vesicles-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Inguinal Mass-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Injection Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Injection Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Injection Site Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Insomnia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Insomnia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Intermit. Explosive Disorder-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Irritability-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Irritable Bowel Syndrome-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Joint Dislocation-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Joint Sprain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Joint Swelling-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Joint Swelling-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Laryngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Laryngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Laryngitis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Lethargy-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Limb Injury-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lip Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Livedo Reticularis-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lung Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lung Infection-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lymphadenopathy-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0021 OG003

Malaise-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Malaise-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Memory Impairment-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Middle Ear Effusion-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Migraine-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Migraine-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Migraine-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Migraine-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Migraine-non-SAE, R, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Mouth Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Muscle Strain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Muscular Weakness-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Musculoskeletal Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Musculoskeletal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Musculoskeletal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Myalgia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Myalgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Myopia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nasal Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasal Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Nasal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nasal Mucosal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasal Polyps-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasopharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0005 OG0011 OG0020 OG003

Nasopharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nausea-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0013 OG0021 OG003

Nausea-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nausea-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nausea-non-SAE, R, Mild

Title	Measurements
	OG0004 OG0011 OG0021 OG003

Nausea-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Oedema Peripheral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Oedema Peripheral-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Oral Herpes-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Oropharyngeal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Oropharyngeal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Osteomyelitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Osteopenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Otitis Externa-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Otitis Media-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0013 OG0021 OG003

Otitis Media-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, NR, Mild

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Pain In Extremity-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, R, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Paraesthesia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Paronychia-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Periorbital Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Pharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0011 OG0020 OG003

Pharyngitis Streptococcal-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Pneumonia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pneumonia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Pneumonia Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Pneumonia Streptococcal-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Procedural Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pyrexia-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0013 OG0020 OG003

Pyrexia-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pyrexia-non-SAE, R, Mild

Title	Measurements
	OG0005 OG0012 OG0020 OG003

Pyrexia-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rales-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rash-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Rash-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Rash Erythematous-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Rash Macular-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rash Papular-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Rash Pruritic-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Respiratory Rate Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Respir. Tract Infect. Viral-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0012 OG0020 OG003

Respir. Tract Infect Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Rhinitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Rhinitis Allergic-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rhinorrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Road Traffic Accident-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Scleritis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Scleritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Scoliosis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Sinus Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinus Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Sinus Disorder-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Sinus Headache-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinus Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0011 OG0020 OG003

Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0007 OG0014 OG0026 OG003

Sinusitis-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinusitis Fungal-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Skin Laceration-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Skin Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Skin Papilloma-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Skin Warm-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sports Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Streptococcal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Subcutaneous Abscess-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Suicidal Ideation-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sunburn-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Tendonitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Tooth Fracture-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Tooth Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Toothache-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Tourette's Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Upper Respir. Tract Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Upper Respir. Tract Infection-non-SAE, NR, Mild

Title	Measurements
	OG0004 OG0013 OG0023 OG003

Upper Respir. Tract Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0011 OG0020 OG003

Urinary Tract Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Urticaria-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Urticaria-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Vaginal Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Vaginitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Varicose Vein-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Varicose Vein-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Vestibulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Viral Infection-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0012 OG0020 OG003

Viral Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Viral Skin Infection-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Viral Upper Respir. Tract Infect-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Viral Up. Respir Tract Infec-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Vitamin D Deficiency-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Vomiting-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0011 OG0021 OG003

Vomiting-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Vomiting-non-SAE, R, Mild

Title	Measurements
	OG0008 OG0010 OG0020 OG003

Vomiting-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Vulvovaginal Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Vulvovaginal Mycotic Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Wheezing-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Wound-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Abdominal Discomfort- non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG0030.00 OG0040.04 OG0050.04

Abdominal Distension-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Distension-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Distension-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Abdominal Distension-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Abdominal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Abdominal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.10 OG0020.17 OG003

Abdominal Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Acne-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Acne-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Acute Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Addison's Disease-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Addison's Disease-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Alopecia-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Ammonia Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Animal Bite-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Anorexia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Anxiety-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Aphthous Stomatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Arthralgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.10 OG0020.17 OG003

Arthralgia-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Arthralgia-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Arthralgia-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Arthritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Arthropod Bite-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Asthenia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Asthma-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthma-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Asthma-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Asthma Exercise Induced-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

ADHD-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Back Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Back Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Back Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Biliary Tract Infection Bacterial-SAE, NR, Moderat

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Blepharitis-non-SAE,NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Blepharitis-non-SAE,NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

B.P. Diastolic Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.33 OG003

Blood Pressure Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Blood Pressure Increased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

B.P. Systolic Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

B.P. Systolic Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

B.P. Systolic Increased-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.16 OG0020.17 OG003

B.P. Systolic Increased-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Breast Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Breath Sounds Abnormal-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Bronchitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Bronchitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Bursitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Cardiac Murmur-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Centrl Venous Catheterisation-non-SAE, NR, Moderat

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Cervical Spinal Stenosis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chest Pain-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chills-non-SAE, R, Mild

Title	Measurements
	OG0000.75 OG0010.00 OG0020.00 OG003

Chills-non-SAE, R, Moderate

Title	Measurements
	OG0000.75 OG0010.00 OG0020.00 OG003

C.O.P.D.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

C.O.P.D.-non-SAE, NR, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Chronic Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Chronic Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Confusional State-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Conjunctival Hyperaemia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Conjunctivitis Allergic-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Conjunctivitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Conjunctivitis Infective-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Conjunctivitis Infective-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Constipation-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Constipation-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Contusion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Contusion-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Convulsion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Convulsion-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Costochondritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Costochondritis-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Cough-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Cough-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Croup Infectious-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Croup Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Cryptosporidiosis Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Cystitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dental Caries-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dermatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dermatitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Dermatitis Contact-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.08 OG0020.17 OG003

Device Failure-non-SAE, NR, Mild

Title	Measurements
	OG0000.23 OG0010.00 OG0020.00 OG003

Diarrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.07 OG0020.00 OG003

Diarrhoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.17 OG0020.17 OG003

Diarrhoea-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.33 OG003

Diarrhoea Haemorrhagic-non-SAE, NR,Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Diarrhoea Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Diverticulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Drug Eruption-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Dyspepsia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Dyspnoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Dyspnoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dyspnoea-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Ear Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Ear Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.06 OG0020.17 OG003

Ear Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Eczema-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Eczema-non-SAE, NR, Severe

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Epistaxis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Epistaxis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.14 OG003

Excoriation-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Exostosis-non-SAE, NR,Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Eye Infection Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.38 OG0010.10 OG0020.00 OG003

Eye Irritation-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Eye Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Fall-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Fatigue-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Fatigue-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Fatigue-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.16 OG0020.00 OG003

Fatigue-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Flank Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Flatulence-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Flatulence-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Folliculitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Fungal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Furuncle-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Gastric Ulcer-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Gastric Ulcer-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Gastroenteritis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gastroenteritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Gastroenteritis-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gastroenteritis Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000.23 OG0010.06 OG0020.00 OG003

Gastroenteritis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Goitre-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gravitational Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Haematochezia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Haemoglobin Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Haemorrhoids-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Head Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Headache-non-SAE, NR, Mild

Title	Measurements
	OG0000.23 OG0010.17 OG0020.17 OG003

Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Headache-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Headache-non-SAE, R, Mild

Title	Measurements
	OG0001.10 OG0010.20 OG0020.17 OG003

Headache-non-SAE, R, Moderate

Title	Measurements
	OG0000.63 OG0010.07 OG0020.17 OG003

Headache-non-SAE, R, Severe

Title	Measurements
	OG0000.38 OG0010.07 OG0020.00 OG003

Heart Rate Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.50 OG003

Heart Rate Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.25 OG0020.00 OG003

Heart Rate Increased-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.25 OG003

Heart Rate Increased-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Hiatus Hernia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Hordeolum-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Hyperlipidaemia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Hypoxia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Implant Site Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.08 OG0020.17 OG003

Influenza-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Influenza-non-SAE, NR, Moderate

Title	Measurements
	OG0000.23 OG0010.07 OG0020.00 OG003

Infusion Related Reaction-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Infusion Site Erythema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.17 OG003

Infusion Site Haematoma-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Haemorrhage-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Irritation-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.10 OG0020.00 OG003

Infusion Site Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Pain-non-SAE, R, Mild

Title	Measurements
	OG0000.20 OG0010.14 OG0020.15 OG003

Infusion Site Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.17 OG003

Infusion Site Pruritus-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Infusion Site Pruritus-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.15 OG0020.17 OG003

Infusion Site Pruritus-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Infusion Site Rash-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Infusion Site Rash-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Infusion Site Reaction-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Swelling-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Infusion Site Swelling-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Vesicles-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Inguinal Mass-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Injection Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Injection Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Injection Site Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Insomnia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Insomnia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Intermit. Explosive Disorder-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Irritability-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Irritable Bowel Syndrome-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Joint Dislocation-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Joint Sprain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.17 OG0020.00 OG003

Joint Swelling-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Joint Swelling-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Laryngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Laryngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Laryngitis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Lethargy-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Limb Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lip Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Livedo Reticularis-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lung Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lung Infection-non-SAE, NR, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lymphadenopathy-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Malaise-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Malaise-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.10 OG0020.00 OG003

Memory Impairment-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Middle Ear Effusion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, NR, Severe

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, R, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Mouth Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Muscle Strain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Muscular Weakness-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Musculoskeletal Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Musculoskeletal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Musculoskeletal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Myalgia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Myalgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Myopia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.10 OG0020.00 OG003

Nasal Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasal Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Nasal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Nasal Mucosal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasal Polyps-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasopharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Nasopharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Nausea-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.17 OG003

Nausea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Nausea-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nausea-non-SAE, R, Mild

Title	Measurements
	OG0000.75 OG0010.08 OG0020.17 OG003

Nausea-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Oedema Peripheral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Oedema Peripheral-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Oral Herpes-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Oropharyngeal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.08 OG0020.00 OG003

Oropharyngeal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.23 OG0010.00 OG0020.00 OG003

Osteomyelitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Osteopenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Otitis Externa-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Otitis Media-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.13 OG0020.17 OG003

Otitis Media-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.17 OG0020.00 OG003

Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, NR, Mild

Title	Measurements
	OG0000.38 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Pain In Extremity-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, R, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Paraesthesia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Paronychia-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Periorbital Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.50 OG0010.08 OG0020.00 OG003

Pharyngitis Streptococcal-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pneumonia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pneumonia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pneumonia Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Pneumonia Streptococcal-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Procedural Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pyrexia-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.07 OG0020.00 OG003

Pyrexia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pyrexia-non-SAE, R, Mild

Title	Measurements
	OG0000.63 OG0010.17 OG0020.00 OG003

Pyrexia-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rales-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rash-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rash-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Rash Erythematous-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Rash Macular-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rash Papular-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Rash Pruritic-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Respiratory Rate Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Respir. Tract Infect. Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.17 OG0020.00 OG003

Respir. Tract Infect Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Rhinitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Rhinitis Allergic-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rhinorrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Road Traffic Accident-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Scleritis-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Scleritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Scoliosis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Sinus Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sinus Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Sinus Disorder-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Sinus Headache-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sinus Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0000.50 OG0010.07 OG0020.00 OG003

Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.46 OG0010.00 OG0020.00 OG003

Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.07 OG0020.17 OG003

Sinusitis-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sinusitis Fungal-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Skin Laceration-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Skin Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Skin Papilloma-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Skin Warm-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Sports Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Streptococcal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Subcutaneous Abscess-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Suicidal Ideation-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sunburn-non-SAE, NR, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Tendonitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Tooth Fracture-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Tooth Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Toothache-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Tourette's Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Upper Respir. Tract Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Upper Respir. Tract Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.17 OG003

Upper Respir. Tract Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Urinary Tract Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Urticaria-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Urticaria-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Vaginal Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Vaginitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Varicose Vein-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Varicose Vein-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Vestibulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Viral Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Viral Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.38 OG0010.00 OG0020.00 OG003

Viral Skin Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Viral Upper Respir. Tract Infect-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Viral Up. Respir Tract Infec-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Vitamin D Deficiency-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Vomiting-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.07 OG0020.17 OG003

Vomiting-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Vomiting-non-SAE, R, Mild

Title	Measurements
	OG0000.75 OG0010.00 OG0020.00 OG003

Vomiting-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Vulvovaginal Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Vulvovaginal Mycotic Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Wheezing-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Wound-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Title

Denominators

Categories

Abdominal Discomfort- non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG0030 OG0042 OG0052

Abdominal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Acne-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Acute Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Alopecia-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Ammonia Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Animal Bite-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Anorexia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Anxiety-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Aphthous Stomatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Arthralgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Arthralgia-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Arthralgia-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Arthritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Arthropod Bite-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Asthenia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthma-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthma-non-SAE, NR, Moderate

Title	Measurements
	OG0003 OG0010 OG0021 OG003

Asthma-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Asthma Exercise Induced-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

ADHD-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Back Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Back Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Back Pain-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Biliary Tract Infection Bacterial-SAE, NR, Moderat

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Blepharitis-non-SAE,NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

B.P. Diastolic Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0022 OG003

Blood Pressure Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Blood Pressure Increased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

B.P. Systolic Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

B.P. Systolic Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

B.P. Systolic Increased-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0014 OG0022 OG003

B.P. Systolic Increased-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Breast Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Bronchitis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Bronchitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Bursitis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Cardiac Murmur-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Centrl Venous Catheterisation-non-SAE, NR, Moderat

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Cervical Spinal Stenosis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chest Pain-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chills-non-SAE, R, Mild

Title	Measurements
	OG0007 OG0010 OG0020 OG003

Chills-non-SAE, R, Moderate

Title	Measurements
	OG0006 OG0010 OG0020 OG003

C.O.P.D.-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

C.O.P.D.-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Chronic Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Confusional State-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Conjunctival Hyperaemia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Conjunctivitis Allergic-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Conjunctivitis Infective-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Constipation-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Constipation-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Contusion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Contusion-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Convulsion-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Convulsion-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Cough-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Cough-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Croup Infectious-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Croup Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Cryptosporidiosis Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Dental Caries-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dermatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dermatitis Contact-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Device Failure-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Diarrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Diarrhoea-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0012 OG0021 OG003

Diarrhoea-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Diarrhoea Haemorrhagic-non-SAE, NR,Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Diarrhoea Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Diverticulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Drug Eruption-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Dyspnoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dyspnoea-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Ear Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Ear Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Ear Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Eczema-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Eczema-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Epistaxis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Epistaxis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Excoriation-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Eye Infection Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0003 OG0011 OG0020 OG003

Fall-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Fatigue-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Fatigue-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Fatigue-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0013 OG0020 OG003

Fatigue-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Flank Pain-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Fungal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Furuncle-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Gastric Ulcer-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Gastric Ulcer-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Gastroenteritis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Gastroenteritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Gastroenteritis-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Gastroenteritis Viral-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Gastroenteritis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Goitre-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Gravitational Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Haematochezia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Haemoglobin Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Haemorrhoids-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Head Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Headache-non-SAE, NR, Mild

Title	Measurements
	OG0007 OG0013 OG0022 OG003

Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0004 OG0010 OG0022 OG003

Headache-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Headache-non-SAE, R, Mild

Title	Measurements
	OG00019 OG0014 OG0021 OG003

Headache-non-SAE, R, Moderate

Title	Measurements
	OG0008 OG0011 OG0021 OG003

Headache-non-SAE, R, Severe

Title	Measurements
	OG0003 OG0011 OG0020 OG003

Heart Rate Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0023 OG003

Heart Rate Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Heart Rate Increased-non-SAE, R, Mild

Title	Measurements
	OG0004 OG0014 OG0023 OG003

Heart Rate Increased-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Hiatus Hernia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Hordeolum-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Hyperlipidaemia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Hypoxia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Implant Site Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infection-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Influenza-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0013 OG0020 OG003

Influenza-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0014 OG0020 OG003

Infusion Related Reaction-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Infusion Site Erythema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Infusion Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0022 OG003

Infusion Site Haematoma-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Haemorrhage-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Irritation-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Infusion Site Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Infusion Site Pain-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0018 OG0022 OG003

Infusion Site Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0015 OG0021 OG003

Infusion Site Pruritus-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Pruritus-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Infusion Site Pruritus-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Rash-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Rash-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Infusion Site Reaction-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Swelling-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Swelling-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Infusion Site Vesicles-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Inguinal Mass-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Injection Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Insomnia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Insomnia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Intermit. Explosive Disorder-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Irritability-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Irritable Bowel Syndrome-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Joint Dislocation-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Laryngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Laryngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Lethargy-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Limb Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Lip Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Livedo Reticularis-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lung Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lung Infection-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lymphadenopathy-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Malaise-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Malaise-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Middle Ear Effusion-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Migraine-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Migraine-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Migraine-non-SAE, R, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Mouth Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Muscular Weakness-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Musculoskeletal Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Musculoskeletal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Musculoskeletal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Myalgia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Myalgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Myopia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nasal Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasal Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Nasal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nasal Mucosal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasal Polyps-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasopharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Nasopharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nausea-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Nausea-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Nausea-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nausea-non-SAE, R, Mild

Title	Measurements
	OG0004 OG0010 OG0020 OG003

Oedema Peripheral-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Oral Herpes-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Oropharyngeal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Oropharyngeal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Osteomyelitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Otitis Externa-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Otitis Media-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0013 OG0021 OG003

Otitis Media-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, NR, Mild

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pain In Extremity-non-SAE, R, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Paraesthesia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Paronychia-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Periorbital Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0011 OG0020 OG003

Pharyngitis Streptococcal-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Pneumonia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Pneumonia Streptococcal-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Procedural Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pyrexia-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0020 OG003

Pyrexia-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Pyrexia-non-SAE, R, Mild

Title	Measurements
	OG0005 OG0012 OG0020 OG003

Pyrexia-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rash-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Rash-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Rash Erythematous-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Rash Macular-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rash Papular-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Rash Pruritic-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Respiratory Rate Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Respir. Tract Infect. Viral-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0012 OG0020 OG003

Respir. Tract Infect Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Rhinitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Rhinitis Allergic-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Rhinorrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Road Traffic Accident-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Scleritis-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Scleritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Scoliosis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Sinus Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinus Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Sinus Disorder-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Sinus Headache-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinus Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0011 OG0020 OG003

Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0006 OG0014 OG0024 OG003

Sinusitis-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinusitis Fungal-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Skin Laceration-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Skin Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Skin Papilloma-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Skin Warm-non-SAE, R, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Streptococcal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Subcutaneous Abscess-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Suicidal Ideation-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sunburn-non-SAE, NR, Severe

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Tendonitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Tooth Fracture-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Tooth Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Toothache-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Tourette's Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Upper Respir. Tract Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Upper Respir. Tract Infection-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0013 OG0023 OG003

Upper Respir. Tract Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Urinary Tract Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Urticaria-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Urticaria-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Vaginal Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Vaginitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Varicose Vein-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Varicose Vein-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Viral Infection-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0012 OG0020 OG003

Viral Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Viral Skin Infection-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Viral Upper Respir. Tract Infect-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Vitamin D Deficiency-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Vomiting-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0011 OG0021 OG003

Vomiting-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Vomiting-non-SAE, R, Mild

Title	Measurements
	OG0008 OG0010 OG0020 OG003

Vomiting-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Vulvovaginal Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Vulvovaginal Mycotic Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Wheezing-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Abdominal Discomfort- non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG0030.00 OG0040.05 OG0050.05

Abdominal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.10 OG0020.00 OG003

Acne-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Acute Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Alopecia-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Ammonia Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Animal Bite-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Anorexia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Anxiety-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Aphthous Stomatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Arthralgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.11 OG0020.00 OG003

Arthralgia-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Arthralgia-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Arthritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Arthropod Bite-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Asthenia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthma-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthma-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Asthma-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Asthma Exercise Induced-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

ADHD-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Back Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Back Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Back Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Biliary Tract Infection Bacterial-SAE, NR, Moderat

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Blepharitis-non-SAE,NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

B.P. Diastolic Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.33 OG003

Blood Pressure Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Blood Pressure Increased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

B.P. Systolic Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

B.P. Systolic Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

B.P. Systolic Increased-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.16 OG0020.17 OG003

B.P. Systolic Increased-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Breast Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Bronchitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Bronchitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Bursitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Cardiac Murmur-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Centrl Venous Catheterisation-non-SAE, NR, Moderat

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Cervical Spinal Stenosis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chest Pain-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chills-non-SAE, R, Mild

Title	Measurements
	OG0000.75 OG0010.00 OG0020.00 OG003

Chills-non-SAE, R, Moderate

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

C.O.P.D.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

C.O.P.D.-non-SAE, NR, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Chronic Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Confusional State-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Conjunctival Hyperaemia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Conjunctivitis Allergic-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Conjunctivitis Infective-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Constipation-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Constipation-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Contusion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Contusion-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Convulsion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Convulsion-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Cough-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Cough-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Croup Infectious-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Croup Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Cryptosporidiosis Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Dental Caries-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dermatitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dermatitis Contact-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Device Failure-non-SAE, NR, Mild

Title	Measurements
	OG0000.23 OG0010.00 OG0020.00 OG003

Diarrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.06 OG0020.00 OG003

Diarrhoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.17 OG0020.17 OG003

Diarrhoea-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Diarrhoea Haemorrhagic-non-SAE, NR,Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Diarrhoea Infectious-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Diverticulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Drug Eruption-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Dyspnoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dyspnoea-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Ear Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Ear Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.06 OG0020.17 OG003

Ear Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Eczema-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Eczema-non-SAE, NR, Severe

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Epistaxis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Epistaxis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.14 OG003

Excoriation-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Eye Infection Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.38 OG0010.10 OG0020.00 OG003

Fall-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Fatigue-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Fatigue-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Fatigue-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.17 OG0020.00 OG003

Fatigue-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Flank Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Fungal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Furuncle-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Gastric Ulcer-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Gastric Ulcer-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Gastroenteritis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gastroenteritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Gastroenteritis-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gastroenteritis Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.06 OG0020.00 OG003

Gastroenteritis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Goitre-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gravitational Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Haematochezia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Haemoglobin Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Haemorrhoids-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Head Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Headache-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.13 OG0020.17 OG003

Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Headache-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Headache-non-SAE, R, Mild

Title	Measurements
	OG0001.10 OG0010.23 OG0020.17 OG003

Headache-non-SAE, R, Moderate

Title	Measurements
	OG0000.63 OG0010.07 OG0020.17 OG003

Headache-non-SAE, R, Severe

Title	Measurements
	OG0000.38 OG0010.07 OG0020.00 OG003

Heart Rate Decreased-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.50 OG003

Heart Rate Increased-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.25 OG0020.00 OG003

Heart Rate Increased-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.25 OG003

Heart Rate Increased-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Hiatus Hernia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Hordeolum-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Hyperlipidaemia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Hypoxia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Implant Site Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.08 OG0020.00 OG003

Influenza-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Influenza-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.07 OG0020.00 OG003

Infusion Related Reaction-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Infusion Site Erythema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.17 OG003

Infusion Site Haematoma-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Haemorrhage-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Irritation-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.10 OG0020.00 OG003

Infusion Site Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Pain-non-SAE, R, Mild

Title	Measurements
	OG0000.20 OG0010.14 OG0020.15 OG003

Infusion Site Pain-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.17 OG003

Infusion Site Pruritus-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Infusion Site Pruritus-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.17 OG003

Infusion Site Pruritus-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Infusion Site Rash-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Infusion Site Rash-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Infusion Site Reaction-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Swelling-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Swelling-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Infusion Site Vesicles-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Inguinal Mass-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Injection Site Haematoma-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Insomnia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Insomnia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Intermit. Explosive Disorder-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Irritability-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Irritable Bowel Syndrome-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Joint Dislocation-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Laryngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Laryngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Lethargy-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Limb Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Lip Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Livedo Reticularis-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lung Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lung Infection-non-SAE, NR, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lymphadenopathy-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Malaise-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Malaise-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.10 OG0020.00 OG003

Middle Ear Effusion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, NR, Severe

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, R, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Mouth Ulceration-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Muscular Weakness-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Musculoskeletal Chest Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Musculoskeletal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Musculoskeletal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Myalgia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Myalgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Myopia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.10 OG0020.00 OG003

Nasal Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasal Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Nasal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Nasal Mucosal Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasal Polyps-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasopharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Nasopharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Nausea-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.07 OG0020.00 OG003

Nausea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Nausea-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nausea-non-SAE, R, Mild

Title	Measurements
	OG0000.75 OG0010.00 OG0020.00 OG003

Oedema Peripheral-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Oral Herpes-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Oropharyngeal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Oropharyngeal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Osteomyelitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Otitis Externa-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Otitis Media-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.13 OG0020.17 OG003

Otitis Media-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.17 OG0020.00 OG003

Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, NR, Mild

Title	Measurements
	OG0000.38 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pain In Extremity-non-SAE, R, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Paraesthesia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Paronychia-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Periorbital Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.50 OG0010.08 OG0020.00 OG003

Pharyngitis Streptococcal-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pneumonia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pneumonia Streptococcal-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Procedural Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pyrexia-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.06 OG0020.00 OG003

Pyrexia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Pyrexia-non-SAE, R, Mild

Title	Measurements
	OG0000.63 OG0010.17 OG0020.00 OG003

Pyrexia-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rash-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rash-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Rash Erythematous-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Rash Macular-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rash Papular-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Rash Pruritic-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Respiratory Rate Increased-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Respir. Tract Infect. Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.17 OG0020.00 OG003

Respir. Tract Infect Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Rhinitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Rhinitis Allergic-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Rhinorrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Road Traffic Accident-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Scleritis-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Scleritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Scoliosis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Sinus Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sinus Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Sinus Disorder-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.06 OG0020.00 OG003

Sinus Headache-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sinus Headache-non-SAE, NR, Moderate

Title	Measurements
	OG0000.50 OG0010.07 OG0020.00 OG003

Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.46 OG0010.00 OG0020.00 OG003

Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.07 OG0020.17 OG003

Sinusitis-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sinusitis Fungal-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Skin Laceration-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Skin Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Skin Papilloma-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Skin Warm-non-SAE, R, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Streptococcal Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Subcutaneous Abscess-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Suicidal Ideation-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Sunburn-non-SAE, NR, Severe

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Tendonitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Tooth Fracture-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Tooth Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Toothache-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Tourette's Disorder-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Upper Respir. Tract Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Upper Respir. Tract Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.23 OG0010.08 OG0020.17 OG003

Upper Respir. Tract Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Urinary Tract Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Urticaria-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Urticaria-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Vaginal Lesion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Vaginitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Varicose Vein-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Varicose Vein-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Viral Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Viral Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.38 OG0010.00 OG0020.00 OG003

Viral Skin Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Viral Upper Respir. Tract Infect-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Vitamin D Deficiency-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Vomiting-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.07 OG0020.17 OG003

Vomiting-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Vomiting-non-SAE, R, Mild

Title	Measurements
	OG0000.75 OG0010.00 OG0020.00 OG003

Vomiting-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Vulvovaginal Candidiasis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Vulvovaginal Mycotic Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Wheezing-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Title

Denominators

Categories

Abdominal Discomfort- non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG0030 OG0041 OG0051

Abdominal Distension-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Distension-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Distension-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Abdominal Distension-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Abdominal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Abdominal Pain Upper-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Abdominal Pain Upper-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Abdominal Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Acne-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Addison's Disease-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Addison's Disease-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Arthralgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Arthralgia-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Asthenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Back Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Back Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Blepharitis-non-SAE,NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Breath Sounds Abnormal-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Bronchitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chronic Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Chronic Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Conjunctivitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Conjunctivitis Infective-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Costochondritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Costochondritis-non-SAE, NR, Severe

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Cough-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Cystitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Dermatitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Dermatitis Contact-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Diarrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Diarrhoea-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Diarrhoea-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0022 OG003

Dyspepsia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Dyspnoea-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Ear Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Exostosis-non-SAE, NR,Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Eye Infection Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Eye Irritation-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Eye Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Fatigue-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Flatulence-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Flatulence-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Folliculitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Gastroenteritis Viral-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Headache-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0012 OG0021 OG003

Headache-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Influenza-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Infusion Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Infusion Site Haemorrhage-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Pain-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Infusion Site Pruritus-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Injection Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Injection Site Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Joint Sprain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Joint Swelling-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Joint Swelling-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Laryngitis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Limb Injury-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Lymphadenopathy-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0021 OG003

Memory Impairment-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Migraine-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Migraine-non-SAE, R, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Muscle Strain-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Nasal Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasal Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nasopharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0011 OG0020 OG003

Nasopharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Nausea-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Nausea-non-SAE, R, Mild

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Nausea-non-SAE, R, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Oedema Peripheral-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Oral Herpes-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Oropharyngeal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Oropharyngeal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Osteopenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Pain In Extremity-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Pharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pneumonia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Pneumonia Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Pyrexia-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Rales-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Respir. Tract Infect. Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Respir. Tract Infect Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0022 OG003

Sports Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Upper Respir. Tract Infection-non-SAE, NR, Mild

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Upper Respir. Tract Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Urinary Tract Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Vestibulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Viral Up. Respir Tract Infec-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Vomiting-non-SAE, NR, Mild

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Wound-non-SAE, NR, Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Abdominal Discomfort- non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG0030.00 OG0040.04 OG0050.04

Abdominal Distension-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Distension-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Distension-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Distension-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Abdominal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Abdominal Pain Upper-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Abdominal Pain Upper-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Abdominal Tenderness-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Acne-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Addison's Disease-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Addison's Disease-non-SAE, NR, Moderate

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Arthralgia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Arthralgia-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Asthenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Back Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Back Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Blepharitis-non-SAE,NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Breath Sounds Abnormal-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Bronchitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chronic Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Chronic Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Conjunctivitis Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Conjunctivitis Infective-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Costochondritis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Costochondritis-non-SAE, NR, Severe

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Cough-non-SAE, NR, Mild

Title	Measurements
	OG0000.50 OG0010.00 OG0020.00 OG003

Cystitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Dermatitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Dermatitis Contact-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Diarrhoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Diarrhoea-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Diarrhoea-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.33 OG003

Dyspepsia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Dyspnoea-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Ear Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Exostosis-non-SAE, NR,Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Eye Infection Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Eye Irritation-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Eye Oedema-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Fatigue-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Flatulence-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Flatulence-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Folliculitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Gastroenteritis Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Headache-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.17 OG0020.17 OG003

Headache-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.16 OG0020.00 OG003

Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Influenza-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Infusion Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Infusion Site Haemorrhage-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.07 OG0020.00 OG003

Infusion Site Oedema-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Pain-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Infusion Site Pruritus-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Injection Site Haematoma-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Injection Site Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Joint Sprain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.17 OG0020.00 OG003

Joint Swelling-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Joint Swelling-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Laryngitis Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Limb Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Lymphadenopathy-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Memory Impairment-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Migraine-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Migraine-non-SAE, R, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Muscle Strain-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Nasal Congestion-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasal Congestion-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nasopharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.08 OG0020.00 OG003

Nasopharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Nausea-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Nausea-non-SAE, R, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.17 OG003

Nausea-non-SAE, R, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Oedema Peripheral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Oral Herpes-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Oropharyngeal Pain-non-SAE, NR, Mild

Title	Measurements
	OG0000.20 OG0010.00 OG0020.00 OG003

Oropharyngeal Pain-non-SAE, NR, Moderate

Title	Measurements
	OG0000.23 OG0010.00 OG0020.00 OG003

Osteopenia-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pain In Extremity-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Pharyngitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Pharyngitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pneumonia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Pneumonia Bacterial-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.17 OG003

Pyrexia-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Rales-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Respir. Tract Infect. Viral-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Respir. Tract Infect Viral-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Sinusitis-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Sinusitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.17 OG003

Sports Injury-non-SAE, NR, Mild

Title	Measurements
	OG0000.00 OG0010.08 OG0020.00 OG003

Upper Respir. Tract Infection-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Upper Respir. Tract Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Urinary Tract Infection-non-SAE, NR, Moderate

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Vestibulitis-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Viral Up. Respir Tract Infec-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Vomiting-non-SAE, NR, Mild

Title	Measurements
	OG0000.25 OG0010.00 OG0020.00 OG003

Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Wound-non-SAE, NR, Moderate

Title	Measurements
	OG0000.00 OG0010.00 OG0020.00 OG003

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG00022.2 OG00127.8 OG0022.2

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG0009.9 OG00110.2 OG0028.7

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG0007.8 OG0018.3 OG0026.5

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0003.5 OG0014.3 OG0020.8

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0003.1 OG0013.8 OG0021.3

Total SC (N = 2294, 1757, 537)

Title	Measurements
	OG0005.5 OG0016.1 OG0023.5

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG00030.9 OG00135.8 OG00213.3

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG00015.0 OG00115.8 OG00211.9

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG00011.6 OG00112.6 OG0028.1

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0008.7 OG0018.9 OG0028.3

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0009.4 OG00110.5 OG0026.1

Total SC (N = 2294, 1757, 537)

Title	Measurements
	OG00010.9 OG00111.8 OG0028.2

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG00028.5 OG00132.7 OG00213.3

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG00011.8 OG00112.2 OG00210.3

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG00010.1 OG00111.2 OG0026.5

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0007.2 OG0017.2 OG0027.5

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0007.3 OG0018.1 OG0024.8

Total SC (N = 2294, 1757, 537)

Title	Measurements
	OG0008.8 OG0019.3 OG0026.9

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG00028.0 OG00132.1 OG00213.3

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG0007.6 OG0017.7 OG0027.1

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG0007.8 OG0018.3 OG0026.5

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0006.1 OG0015.7 OG0027.5

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0006.3 OG0016.9 OG0024.4

Total SC (N = 2294, 1757, 537)

Title	Measurements
	OG0006.8 OG0017.0 OG0026.0

Title

Denominators

Categories

Study Part 1 (IV) (n= 11)

Title	Measurements
	OG0000.0 OG0010.00

Study Part 2 (SC) (n= 11)

Title	Measurements
	OG00018.2 OG0010.00

Study Part 3A (SC) (n=10)

Title	Measurements
	OG0000.00 OG0010.00

Study Part 3B (SC) (n=10)

Title	Measurements
	OG0000.00 OG0010.00

Study Extension (SC) (n= 9)

Title	Measurements
	OG00011.1 OG0010.00

Study Part 2, 3A, 3B, Study Extension (n= 11)

Title	Measurements
	OG00018.2 OG0010.00

Title

Denominators

Categories

Study Part 1 (IV) (n= 207 Infusions)

Title	Measurements
	OG0006.7(3.6 to 11.3) OG0016.2(3.2 to 10.5)

Study Part 2 (SC) (n= 595 Infusions)

Title	Measurements
	OG0004.2(2.7 to 6.2) OG0010.5(0.1 to 1.3)

Study Part 3A (SC) (n=268 Infusions)

Title	Measurements
	OG0003.1(1.4 to 5.8) OG0010.4(0.0 to 1.7)

Study Part 3B (SC) (n=538 Infusions)

Title	Measurements
	OG0001.1(0.4 to 2.3) OG0010.2(0.0 to 0.8)

Study Extension (SC) (n= 893 Infusions)

Title	Measurements
	OG0000.6(0.2 to 1.2) OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Parts 2, 3A, 3B, & Extension (n= 2,294 Infusions)

Title	Measurements
	OG0001.9(1.4 to 2.5) OG0010.2(0.1 to 0.5)

Title

Denominators

Categories

Study Part 1 (IV) (n= 162 Infusions)

Title	Measurements
	OG0008.7(4.7 to 14.8) OG0018.0(4.2 to 13.8)

Study Part 2 (SC) (n= 469 Infusions)

Title	Measurements
	OG0004.5(2.8 to 6.8) OG0010.6(0.2 to 1.7)

Study Part 3A (SC) (n=206 Infusions)

Title	Measurements
	OG0004.0(1.8 to 7.7) OG0010.5(0.0 to 2.2)

Study Part 3B (SC) (n=418 Infusions)

Title	Measurements
	OG0001.5(0.6 to 3.0) OG0010.2(0.0 to 1.1)

Study Extension (SC) (n= 664 Infusions)

Title	Measurements
	OG0000.6(0.2 to 1.4) OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Parts 2, 3A, 3B, & Extension (n= 1,757 Infusions)

Title	Measurements
	OG0002.2(1.6 to 3.0) OG0010.3(0.1 to 0.6)

Title

Denominators

Categories

Study Part 1 (IV) (n= 45 Infusions)

Title	Measurements
	OG0000.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval. OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Study Part 2 (SC) (n= 126 Infusions)

Title	Measurements
	OG0003.3(1.0 to 7.8) OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Study Part 3A (SC) (n=62 Infusions)

Title	Measurements
	OG0000.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval. OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Study Part 3B (SC) (n=120 Infusions)

Title	Measurements
	OG0000.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval. OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Study Extension (SC) (n= 229 Infusions)

Title	Measurements
	OG0000.4(0.0 to 1.9) OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Parts 2, 3A, 3B, & Extension (n= 537 Infusions)

Title	Measurements
	OG0000.9(0.3 to 2.0) OG0010.0(NA to NA)There were no infusion rate changes; therefore there is no confidence interval.

Title

Denominators

Categories

Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)

Title	Measurements
	OG0001.0 OG0011.2 OG0020.0

Study Part 2 (SC) (N = 595, 469, 126)

Title	Measurements
	OG0004.9 OG0015.1 OG0024.0

Study Part 3a (SC) (N = 268, 206, 62)

Title	Measurements
	OG0002.2 OG0012.9 OG0020.0

Study Part 3b (SC) (N = 538, 418, 120)

Title	Measurements
	OG0001.5 OG0011.9 OG0020.0

Study Extension (SC) (N = 893, 664, 229)

Title	Measurements
	OG0001.1 OG0011.4 OG0020.4

Total SC (N = 2294, 1757, 537)

Title	Measurements
	OG0002.3 OG0012.7 OG0021.1

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California		United States

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins