Pomalidomide for the Treatment of Bleeding in HHT | NCT03910244

Name	Class
RTI International	OTHER

Label	Type	Description	Intervention Names
Pomalidomide	Experimental	Oral Pomalidomide will be provided as a capsule at 4 mg/day dose. There will be 6 treatment cycles of 28 days (4 weeks) each. Total treatment phase duration will be 24 weeks.	Drug: Pomalidomide Oral Product
Placebo	Placebo Comparator	A placebo matching the study drug will be provided as a capsule. There will be 6 treatment cycles of 28 days (4 weeks) each. Total treatment phase duration will be 24 weeks.	Drug: Placebo oral capsule

Name	Type	Description	Arm Group Labels	Other Names
Pomalidomide Oral Product	Drug	Pomalidomide, a third generation derivative of thalidomide, given orally at a starting dose of 4 mg/day for days 1-28 of six 28-day cycles. The dose may be reduced to 3 or 2 mg/day based on specific adverse event (AE) criteria.

Measure	Description	Time Frame
Change From Baseline Epistaxis Severity Score	The primary outcome measure is the change from baseline in Epistaxis Severity Score (ESS) after 6 months of treatment administration to compare the outcomes of Pomalidomide versus Placebo. The ESS ranges from 0-10 with higher scores indicating worse condition in the prior 4 weeks. The minimal important difference is 0.71	4, 8, 12, 16, 20, and 24 Weeks and 4 weeks post treatment

Measure	Description	Time Frame
Average Total Daily Duration of Nosebleeds - Change From Baseline	The daily epistaxis duration is calculated as the total duration of all reported nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint	After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Measure	Description	Time Frame
Average Total Daily Duration of Low Intensity Nosebleeds - Change From Baseline	The daily of low intensity epistaxis duration is calculated as the total duration of "spotting" or "dripping" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint	After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Name	Affiliation	Role
Keith McCrae, MD	The Cleveland Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
UCSD Hemophilia and Thrombosis Treatment Center

PubMed Identifier	Type	Citation	Retractions
25674101	Background	McDonald J, Wooderchak-Donahue W, VanSant Webb C, Whitehead K, Stevenson DA, Bayrak-Toydemir P. Hereditary hemorrhagic telangiectasia: genetics and molecular diagnostics in a new era. Front Genet. 2015 Jan 26;6:1. doi: 10.3389/fgene.2015.00001. eCollection 2015.
20087969	Background	Hoag JB, Terry P, Mitchell S, Reh D, Merlo CA. An epistaxis severity score for hereditary hemorrhagic telangiectasia. Laryngoscope. 2010 Apr;120(4):838-43. doi: 10.1002/lary.20818.

ID	Title	Description
FG000	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
FG001	Placebo	Daily dose of placebo for 24 weeks

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 30, 2022	Apr 3, 2024

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 Epistaxis Severity Score

The primary outcome measure is the change from baseline in Epistaxis Severity Score (ESS) after 6 months of treatment administration to compare the outcomes of Pomalidomide versus Placebo. The ESS ranges from 0-10 with higher scores indicating worse condition in the prior 4 weeks. The minimal important difference is 0.71

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

units on a scale

4, 8, 12, 16, 20, and 24 Weeks and 4 weeks post treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG00049 OG00192

Title

Denominators

Categories

4 Weeks

- ParticipantsOG00049
- ParticipantsOG00192

Title	Measurements
	OG000-1(-1.40 to -0.60)

Secondary

Average Total Daily Duration of Nosebleeds - Change From Baseline

The daily epistaxis duration is calculated as the total duration of all reported nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

minutes

After 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Weighted Average Total Daily Duration of Nosebleeds - Change From Baseline

The daily epistaxis duration is calculated as the total duration of all reported nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary, weighted by the intensity, with 90%% winsorization. The outcome is the change between the baseline diary on the specified timepoint

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

minutes

After 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Average Total Daily Duration of Low Intensity Nosebleeds - Change From Baseline

The daily of low intensity epistaxis duration is calculated as the total duration of "spotting" or "dripping" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

minutes

After 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Average Total Daily Duration of Medium Intensity Nosebleeds - Change From Baseline

The daily of medium intensity epistaxis duration is calculated as the total duration of "dripping quickly" or "steady stream" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

minutes

After 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Average Total Daily Duration of High Intensity Nosebleeds - Change From Baseline

The daily of high intensity epistaxis duration is calculated as the total duration of "gushing" or "pouring" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

minutes

After 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Total Iron Infused

Total iron infused (mg) is calculated as the total in 4 weeks, averaged across all visits reported through the 24-week treatment period. Patients with no infusions have a value of zero.

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Median

Inter-Quartile Range

mg/4 weeks

Baseline through 24 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Total Iron Infused

Total iron infused (mg) is calculated as the total in 4 weeks, averaged across all visits reported through the first 12 weeks of the treatment period. Patients with no infusions have a value of zero.

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Median

Inter-Quartile Range

mg/4 weeks

Baseline through 12 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Total Iron Infused

Total iron infused (mg) is calculated as the total in 4 weeks, averaged across all visits reported through the second 12 weeks of the treatment period. Patients with no infusions have a value of zero.

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Median

Inter-Quartile Range

mg/4 weeks

12 through 24 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Patients With Any Packed Red Blood Cells Transfusion Through 24 Weeks

Patients with any packed red blood cells transfusion through the 24-week treatment period

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Count of Participants

Participants

Baseline through 24 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Total Blood Transfused

Total blood transfused (units of blood) is calculated as the total in 4 weeks, averaged across all visits reported through the 24-week treatment period. Patients with no transfusions have a value of zero.

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Median

Inter-Quartile Range

units of blood/4 weeks

Baseline through 24 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Patients With Any Packed Red Blood Cells Transfusion Through 12 Weeks

Patients with any packed red blood cells transfusion through the first 12 weeks of the treatment period

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Count of Participants

Participants

Baseline through 12 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Total Blood Transfused

Total blood transfused (units of blood) is calculated as the total in 4 weeks, averaged across all visits reported through the first 12 weeks of the treatment period. Patients with no transfusions have a value of zero.

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Median

Inter-Quartile Range

units of blood/4 weeks

Baseline through 12 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Patients With Any Packed Red Blood Cells Transfusion 12-24 Weeks

Patients with any packed red blood cells transfusion through the second 12 weeks of the treatment period

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Count of Participants

Participants

12 through 24 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Total Blood Transfused

Total blood transfused (units of blood) is calculated as the total in 4 weeks, averaged across all visits reported through the second 12 weeks of the treatment period. Patients with no transfusions have a value of zero.

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Median

Inter-Quartile Range

units of blood/4 weeks

12 through 24 Weeks

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Transferrin Saturation

Change from baseline transferrin saturation collected from blood iron studies

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

Percent

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Ferritin

Change from baseline ferritin level collected from blood iron studies

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

ng/mL

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Hemoglobin

Change from baseline Hemoglobin level taken from complete blood counts

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

g/dL

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Hematocrit

Change from baseline Hematocrit level taken from complete blood counts

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

Percent

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Mean Corpuscular Volume (MCV)

Change from baseline MCV level taken from complete blood counts

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Mean Corpuscular Hemoglobin Concentration (MCHC)

Change from baseline MCHC level taken from complete blood counts

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

g/dL

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Pre-specified

Platelets

Change from baseline platelets taken from complete blood counts

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

10^3/uL platelets

After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Neuro-QoL - Satisfaction With Social Roles and Activities - T Score

The outcome measure is the Neuro-QoL Satisfaction with Social Roles and Activities T-Score to compare the outcomes of Pomalidomide versus Placebo. The Neuro-QoL Satisfaction with Social Roles and Activities Short Form (V1.1) T-score has a value of 50 representing the average general US population, with a standard deviation of 10, and with higher scores indicating more satisfaction. The minimal detectable change is 3.7 T score points

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

Patient Reported Outcomes Measurement Information System (PROMIS) - Emotional Distress - Depression - T Score

The outcome measure is the PROMIS Emotional Distress - Depression T-Score to compare the outcomes of Pomalidomide versus Placebo. The PROMIS Emotional Distress-Depression Short Form (V1.0) T-score has a value of 50 representing the average general US population, with a standard deviation of 10, and with higher scores indicating more depression

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

PROMIS - Fatigue - T Score

The outcome measure is the PROMIS Fatigue T-Score to compare the outcomes of Pomalidomide versus Placebo. The PROMIS® Fatigue Short Form (V1.0) T-score has a value of 50 representing the average general US population, with a standard deviation of 10, and with higher scores indicating more fatigue

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Secondary

HHT-Specific QOL Questionnaire - Score

The outcome measure is the HHT-Specific QOL Questionnaire - Score to compare the outcomes of Pomalidomide versus Placebo. The HHT-specific QOL score ranges from 0 to 16 with higher scores indicating more limitations due to HHT in the prior 4 weeks

An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

ID	Title	Description
OG000	Placebo	Daily dose of placebo for 24 weeks
OG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0011 events1 affected95 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0015 events5 affected95 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG00115 events9 affected95 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0009 events5 affected49 at risk EG00170 events41 affected95 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0016 events4 affected95 at risk
Bradycardia	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cardiac failure high output	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cardiac hypertrophy	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cardiomegaly	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Palpitations	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Tachycardia	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hepatic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Ichthyosis	Congenital, familial and genetic disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Hypothyroidism	Endocrine disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Blepharitis	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Corneal scar	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Dry eye	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Eye irritation	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Eye pruritus	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Ulcerative keratitis	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Vision blurred	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Visual impairment	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0011 events1 affected95 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0018 events8 affected95 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 events3 affected49 at risk EG0013 events3 affected95 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0009 events9 affected49 at risk EG00151 events45 affected95 at risk
Dental caries	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0007 events7 affected49 at risk EG0018 events7 affected95 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0019 events9 affected95 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Flatulence	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events1 affected95 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Lip dry	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Melaena	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0008 events8 affected49 at risk EG00116 events15 affected95 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Retching	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Tongue eruption	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Tongue haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Toothache	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0014 events4 affected95 at risk
Asthenia	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Chest discomfort	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Chest pain	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Chills	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Discomfort	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Face oedema	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Fatigue	General disorders	MedDRA 17.1	Non-systematic Assessment	EG00020 events17 affected49 at risk EG00148 events42 affected95 at risk
Feeling abnormal	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Feeling jittery	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Generalised oedema	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Influenza like illness	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Localised oedema	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Loss of control of legs	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Mucosal dryness	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Oedema	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0015 events5 affected95 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG00114 events14 affected95 at risk
Pain	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0014 events4 affected95 at risk
Pyrexia	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected95 at risk
Sensation of foreign body	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Thirst	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Multiple allergies	Immune system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Seasonal allergy	Immune system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Bacteraemia	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Bursitis infective	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Carbuncle	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Conjunctivitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Corona virus infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0009 events9 affected49 at risk EG0019 events9 affected95 at risk
Eye infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Fungal infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hordeolum	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Infective glossitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events1 affected49 at risk EG0010 events0 affected95 at risk
Influenza	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Lip infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Oral herpes	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Sinusitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0014 events4 affected95 at risk
Tonsillitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Tooth abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0003 events2 affected49 at risk EG0013 events3 affected95 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0016 events5 affected95 at risk
Viral pharyngitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0011 events1 affected95 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected95 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events1 affected95 at risk
Cardiac murmur	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0012 events2 affected95 at risk
Heart rate increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
International normalised ratio increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Right ventricular systolic pressure increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Weight increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events2 affected49 at risk EG0012 events2 affected95 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events1 affected49 at risk EG0011 events1 affected95 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events2 affected95 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0014 events4 affected95 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0017 events6 affected95 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0015 events5 affected95 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected95 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0007 events6 affected49 at risk EG00114 events13 affected95 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events3 affected49 at risk EG0014 events4 affected95 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected95 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Focal nodular hyperplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Anosmia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Disturbance in attention	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0008 events7 affected49 at risk EG00117 events16 affected95 at risk
Dysgeusia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 events3 affected49 at risk EG00114 events13 affected95 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events3 affected49 at risk EG0010 events0 affected95 at risk
Hypogeusia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Memory impairment	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Mental impairment	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Migraine	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Neuralgia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events2 affected49 at risk EG0014 events4 affected95 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Presyncope	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Sciatica	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Somnolence	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0011 events1 affected95 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Tremor	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0018 events8 affected95 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected95 at risk
Confusional state	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 events5 affected49 at risk EG0014 events4 affected95 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Renal cyst	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected95 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events3 affected49 at risk EG0012 events2 affected95 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 events5 affected49 at risk EG00124 events22 affected95 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0011 events1 affected95 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0015 events5 affected95 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected95 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected95 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0014 events4 affected95 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected95 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0016 events6 affected95 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG00114 events13 affected95 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG00120 events20 affected95 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected49 at risk EG0014 events4 affected95 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected95 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0016 events5 affected95 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Skin warm	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0017 events6 affected95 at risk
Cataract operation	Surgical and medical procedures	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events1 affected95 at risk
Gastrointestinal endoscopic therapy	Surgical and medical procedures	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Sinus operation	Surgical and medical procedures	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Transurethral bladder resection	Surgical and medical procedures	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Angiopathy	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Fibromuscular dysplasia	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Flushing	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected95 at risk
Haematoma	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Hot flush	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected95 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected95 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Pallor	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Thrombophlebitis	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk
Varicose vein ruptured	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected95 at risk

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013684	Telangiectasis
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Title	Description
BG000	Placebo	Daily dose of placebo for 24 weeks
BG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Daily dose of placebo for 24 weeks	0	49	8	49	43	49
EG001	Pomalidomide	Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks	1	95	22	95	90	95

ID	Term
D013683	Telangiectasia, Hereditary Hemorrhagic
D004844	Epistaxis