A Dose Ranging Study Of PF-00868554 In Combination With P... | NCT00720434

Label	Type	Description	Intervention Names
A	Experimental	500 mg BID	Drug: PF-00868554
B	Experimental	300 mg BID	Drug: PF-00868554
C	Experimental	200 mg BID	Drug: PF-00868554
D	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
PF-00868554	Drug	500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.	A

Measure	Description	Time Frame
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set	Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.	Baseline, Week 4
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set	Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.	Baseline, Week 4

Measure	Description	Time Frame
Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)	Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		La Jolla	California	92037	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.

Arm/Group Information

ID	Title	Description
BG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
BG001	PF-00868554 300 mg + pegIFN Alfa-2a/RBV	PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
BG002	PF-00868554 500 mg + pegIFN Alfa-2a/RBV	PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
BG003	Placebo + pegIFN Alfa-2a/RBV	Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00010 BG0019 BG0028 BG0038 BG00435

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

Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set

Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.

Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 4

ID	Title	Description
OG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
OG001	PF-00868554 300 mg + pegIFN Alfa-2a/RBV	PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
OG002	PF-00868554 500 mg + pegIFN Alfa-2a/RBV	PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
OG003	Placebo + pegIFN Alfa-2a/RBV	Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.

Units	Counts
Participants	OG00010 OG0019 OG0028 OG003

Title

Denominators

Categories

Baseline (n=10, 9, 8, 8)

Title	Measurements
	OG0006.38843± 0.483283 OG0016.67823± 0.472198 OG0026.66254± 0.563548 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.	ANCOVA		0.0131		Adjusted Mean Difference	-2.36357			2-Sided	95	-4.19228	-0.53485				No	Superiority or Other

Secondary

Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.

Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.

Posted

Number

95% Confidence Interval

proportion of participants

Week 4, 12, 48, 60, 72

ID	Title	Description
OG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
OG001	PF-00868554 300 mg + pegIFN Alfa-2a/RBV

Secondary

Alanine Aminotransferase (ALT) Levels

FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively.

Posted

Mean

Standard Deviation

IU/L

Week 4, 12, 48, 72

ID	Title	Description
OG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
OG001	PF-00868554 300 mg + pegIFN Alfa-2a/RBV	PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.

Secondary

Population Pharmacokinetics (PK) of PF-00868554

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Not Posted

1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28

Primary

Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set

Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.

Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline, Week 4

ID	Title	Description
OG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
OG001	PF-00868554 300 mg + pegIFN Alfa-2a/RBV	PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-00868554 200 mg + pegIFN Alfa-2a/RBV	PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.	0	10	10	10
EG001	PF-00868554 300 mg + pegIFN Alfa-2a/RBV	PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.	2	9	9	9
EG002	PF-00868554 500 mg + pegIFN Alfa-2a/RBV	PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.	1	8	8	8
EG003	Placebo + pegIFN Alfa-2a/RBV	Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.	2	8	8	8

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected10 at risk EG0014 affected9 at risk EG0024 affected8 at risk EG0033 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected10 at risk EG0014 affected9 at risk EG0022 affected8 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0022 affected8 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Hypogonadism	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Blepharitis	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Dry eye	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Eye pain	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Visual impairment	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0013 affected9 at risk EG0022 affected8 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0012 affected9 at risk EG0020 affected8 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0022 affected8 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected10 at risk EG0014 affected9 at risk EG0024 affected8 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0012 affected9 at risk EG0021 affected8 at risk EG003
Chest pain	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Chills	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0012 affected9 at risk EG0021 affected8 at risk EG003
Cyst	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Fatigue	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected10 at risk EG0014 affected9 at risk EG0025 affected8 at risk EG003
Influenza like illness	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0012 affected9 at risk EG0021 affected8 at risk EG003
Injection site erythema	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0012 affected9 at risk EG0021 affected8 at risk EG003
Injection site pruritus	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Irritability	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Pain	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Product taste abnormal	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Vestibulitis	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Alveolar osteitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Cellulitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Otitis externa	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Rhinitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Sinusitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Weight decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Weight increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0012 affected9 at risk EG0020 affected8 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Areflexia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0012 affected9 at risk EG0020 affected8 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0022 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected10 at risk EG0016 affected9 at risk EG0024 affected8 at risk EG003
Migraine with aura	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0022 affected8 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Depression	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected10 at risk EG0011 affected9 at risk EG0022 affected8 at risk EG003
Generalised anxiety disorder	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected10 at risk EG0011 affected9 at risk EG0024 affected8 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Menstrual disorder	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Spermatocele	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Varicocele	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected10 at risk EG0012 affected9 at risk EG0020 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0022 affected8 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0012 affected9 at risk EG0020 affected8 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0022 affected8 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0022 affected8 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected9 at risk EG0021 affected8 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0013 affected9 at risk EG0020 affected8 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003
Hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Phlebitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thyroiditis	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG0031 affected8 at risk
Gait disturbance	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Blood creatinine increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0020 affected8 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected9 at risk EG0020 affected8 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected10 at risk EG0010 affected9 at risk EG0021 affected8 at risk EG003