Bardoxolone Methyl Evaluation in Patients With Pulmonary... | NCT02036970

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label	Experimental	Participants received bardoxolone methyl 2.5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards)	Drug: Bardoxolone methyl
Part 1: Dose-Ranging Bardoxolone methyl 5 mg/Part 2: Open-Label	Experimental	Participants received bardoxolone methyl 5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards)	Drug: Bardoxolone methyl
Part 1: Dose-Ranging Bardoxolone methyl 10 mg/Part 2: Open-Label	Experimental	Participants received bardoxolone methyl 10 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards)	Drug: Bardoxolone methyl
Part 1: Dose-Ranging Bardoxolone methyl 20 mg/Part 2: Open-Label	Experimental	Participants received bardoxolone methyl 20 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards)	Drug: Bardoxolone methyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bardoxolone methyl	Drug		Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label Part 1: Dose Titration: Bardoxolone methyl 10 mg/Part 2: Bardoxolone methyl 10 mg Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg

Measure	Description	Time Frame
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo	Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.	Baseline through Week 16

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male and female patients ≥ 18 to ≤ 75 years of age upon study consent;
BMI > 18.5 kg/m²
Symptomatic pulmonary hypertension WHO class II and III;
WHO Group I, III, or V PH according to the following criteria:
1. If diagnosed with WHO Group I PAH, then on of the following subtypes:
  - Idiopathic or heritable PAH;
  - PAH associated with connective tissue disease;
  - PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair;
  - PAH associated with anorexigen or drug-induced toxicity;
  - PAH associated with human immunodeficiency virus (HIV); or
2. If WHO Group III PH then primary diagnosis must be one of the following subtypes:
  - Connective tissue disease associated ILD (CTD-ILD);
  - Idiopathic pulmonary fibrosis (IPF);
  - Nonspecific interstitial pneumonia (NSIP); or
3. If WHO Group V PH then patient must be diagnosed with sarcoidosis;
Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PH
If WHO Group I, has been receiving no more than three (3) FDA-approved disease-specific PAH therapies except for intravenous (iv) prostacyclin/prostacyclin analogues. PAH therapy must be at a stable dose for at least 90 days prior to Day 1;
Has adequate kidney function defined as an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) 4-variable formula;

Exclusion Criteria:

Participation in other interventional clinical studies involving pharmaceutical products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1;
Initiation of an exercise program for cardio-pulmonary rehabilitation within 3 months (90 days) prior to Day 1 or planned initiation during Part 1 of the study;
Stopped receiving any PH chronic therapy within 60 days prior to Day 1;
Requirement for receipt of intravenous inotropes within 30 days prior to Day 1;
Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during Screening after a period of rest;
Has systolic BP < 90 mm Hg during Screening after a period of rest;
WHO Group III or V patients who at rest require supplemental oxygen at a rate of >4 L/min and have peripheral capillary oxygen saturation levels <92%;
Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease,including but not limited to any of the following:
1. Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension;
2. Pericardial constriction;
3. Restrictive or congestive cardiomyopathy;
4. Left ventricular ejection fraction < 40% per echocardiogram (ECHO) within 60 days of Day 1;
5. Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or anginal chest pain);
Acutely decompensated heart failure within 30 days prior to Day 1, as per Investigator assessment;
History of atrial septostomy within 180 days prior to Day 1;
History of obstructive sleep apnea that is untreated;
Has a history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication) defined as mild to severe hepatic impairment (Child-Pugh Class A-C);
Serum aminotransferase (ALT or AST) levels > the upper limit of normal (ULN) at Screening;
For patients with HIV-associated PAH, any of the following:
1. Concomitant active opportunistic infections within 180 days prior to Screening;
2. Detectable viral load within 90 days prior to Screening;
3. Cluster designation (CD+) T-cell count < 200 mm3 within 90 days prior to Screening;
4. Changes in antiretroviral regimen within 90 days prior to Screening;
5. Using inhaled pentamidine

Facility	Status	City	State	ZIP	Country	Contacts
Banner University Medical Center, Phoenix Advanced Lung Disease Institute		Phoenix	Arizona	85004	United States

ID	Title	Description
FG000	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Participants received bardoxolone methyl 2.5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards)
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 26, 2017	Dec 29, 2020

Arm/Group Information

ID	Title	Description
BG000	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 2.5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 2.5 mg once-daily from Week 16 onwards.
BG001	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 5 mg once-daily from Week 16 onwards.
BG002	Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 10 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 wer eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 10 mg once-daily from Week 16 onwards.
BG003	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 20 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 20 mg once-daily from Week 16 onwards.
BG004	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 2.5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 2.5 mg once-daily from Week 16 and onwards.
BG005	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 5 mg once-daily from Week 16 and onwards.
BG006	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.
BG007	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 20 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 20 mg once-daily from Week 16 and onwards.
BG008	Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl 10 mg capsules. Participants initially started with bardoxolone methyl 5 mg once-daily from Day 1 and titrated to bardoxolone methyl 10 mg once-daily starting at Week 4 up to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received the same bardoxolone methyl dose once-daily from Week 16 and onwards.
BG009	Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from Week 20 and onwards.
BG010	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The number analyzed for Part 2 reflects the number of patients who began Part 2 of the study.

Mean

Standard Deviation

years

Title	Denominators	Categories
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16)	ParticipantsBG0006 ParticipantsBG00112 ParticipantsBG00211 ParticipantsBG003

Sex: Female, Male

The number analyzed for Part 2 reflects the number of patients who began Part 2 of the study.

Count of Participants

Participants

Title	Denominators	Categories
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16)	ParticipantsBG0006 ParticipantsBG00112 ParticipantsBG002

Ethnicity (NIH/OMB)

The number analyzed for Part 2 reflects the number of patients who began Part 2 of the study.

Count of Participants

Participants

Title	Denominators	Categories
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16)	ParticipantsBG0006 ParticipantsBG00112 ParticipantsBG002

Race (NIH/OMB)

The number analyzed for Part 2 reflects the number of patients who began Part 2 of the study.

Count of Participants

Participants

Title	Denominators	Categories
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16)	ParticipantsBG0006 ParticipantsBG00112 ParticipantsBG002

6-Minute Walk Test (6MWT)

Modified Intent-to-treat (mITT) population, which included all randomized patients who received at least 28 doses of study treatment, did not undergo heart or lung transplantation during the treatment period, and performed at least one-post baseline 6MWT assessment. Only Part 1 patients are included since the primary outcome is the change from baseline in 6MWD through Week 16.

Mean

Standard Deviation

meters

Title	Denominators	Categories
	ParticipantsBG0006 ParticipantsBG00112 ParticipantsBG002

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 Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo

Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.

mITT population included all randomized patients receiving at least 28 doses of study treatment, did not undergo heart or lung transplantation during the treatment period, and performed at least one-post baseline 6MWD assessment. Only Part 1 patients are included since the primary outcome is the change from baseline in 6MWD through Week 16. Primary outcome assessed for subgroups of participants with PAH from Cohorts 1, 2 and 3 of the study and participants with PH, Cohort 4 of the study.

Posted

Mean

Standard Deviation

meters

Baseline through Week 16

ID	Title	Description
OG000	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 2.5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 2.5 mg once-daily from Week 16 onwards.
OG001	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 5 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 5 mg once-daily from Week 16 onwards.
OG002	Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 10 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 wer eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 10 mg once-daily from Week 16 onwards.
OG003	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 20 mg once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 20 mg once-daily from Week 16 onwards.
OG004	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 2.5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 2.5 mg once-daily from Week 16 and onwards.
OG005	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 5 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 5 mg once-daily from Week 16 and onwards.
OG006	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.
OG007	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 20 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 20 mg once-daily from Week 16 and onwards.
OG008	Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl 10 mg capsules. Participants initially started with bardoxolone methyl 5 mg once-daily from Day 1 and titrated to bardoxolone methyl 10 mg once-daily starting at Week 4 up to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and received the same bardoxolone methyl dose once-daily from Week 16 and onwards.
OG009	Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16. Part 2: Participants who completed treatment in Part 1 were eligible to continue to the extension Part 2 and initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from Week 20 and onwards.

Units	Counts
Participants	OG0006 OG00112 OG0029 OG003

Title	Denominators	Categories
Change from Baseline though Week 16 for participants with PAH	ParticipantsOG0006 ParticipantsOG00112 ParticipantsOG0029 ParticipantsOG003

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 OG001 OG002 OG003 OG004 OG005 OG006 OG007 OG008 OG009	Overall treatment effect in participants with PAH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated and compared with placebo through 16 weeks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment and visit as fixed factors. A compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 used in the model with the change from baseline at Wk16 as primary endpoint.	Mixed Models Analysis		0.8133	The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).	Mean Difference (Net)	-1.74			2-Sided	95	-16.22	12.74

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 2.5 mg once-daily from Day 1 to Week 16.	0	6	0	6	5	6
EG001	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 5 mg once-daily from Day 1 to Week 16.	0	12	1	12	11	12
EG002	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 10 mg once-daily from Day 1 to Week 16.	0	11	0	11	10	11
EG003	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Participants were randomized to receive bardoxolone methyl 20 mg once-daily from Day 1 to Week 16.	0	12	2	12	12	12
EG004	Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 2.5 mg capsules once-daily from Day 1 to Week 16.	0	2	0	2	2	2
EG005	Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 5 mg capsules once-daily from Day 1 to Week 16.	0	4	0	4	4	4
EG006	Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16.	0	3	0	3	3	3
EG007	Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 20 mg capsules once-daily from Day 1 to Week 16.	0	4	1	4	4	4
EG008	Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl 10 mg capsules. Participants initially started with bardoxolone methyl 5 mg once-daily from Day 1 and titrated to bardoxolone methyl 10 mg once-daily starting at Week 4 up to Week 16.	1	74	7	74	64	74
EG009	Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Participants were randomized to receive bardoxolone methyl matching placebo 10 mg capsules once-daily from Day 1 to Week 16.	0	38	2	38	33	38
EG010	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 2: Participants who completed treatment receiving bardoxolone methyl 2.5 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 2.5 mg once-daily from Week 16 onwards.	0	5	2	5	5	5
EG011	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 2: Participants who completed treatment receiving bardoxolone methyl 5 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 5 mg once-daily from Week 16 onwards.	0	11	5	11	11	11
EG012	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 2: Participants who completed treatment receiving bardoxolone methyl 10 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 10 mg once-daily from Week 16 onwards.	0	6	3	6	6	6
EG013	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 2: Participants who completed treatment receiving bardoxolone methyl 20 mg once daily in Part 1 were eligible to continue to the extension Part 2 and continued to receive the same bardoxolone methyl 20 mg once-daily from Week 16 onwards.	0	9	6	9	8	9
EG014	Part 2 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 2: Participants who completed bardoxolone methyl matching placebo 2.5 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 2.5 mg once-daily from Week 16 and onwards.	0	1	0	1	1	1
EG015	Part 2 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 2: Participants who completed bardoxolone methyl matching placebo 5 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 5 mg once-daily from Week 16 and onwards.	0	3	1	3	2	3
EG016	Part 2 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2: Participants who completed bardoxolone methyl matching placebo 10 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.	0	3	2	3	3	3
EG017	Part 2 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 2: Participants who completed bardoxolone methyl matching placebo 20 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 20 mg once-daily from Week 16 and onwards.	0	3	1	3	3	3
EG018	Part 2 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2: Participants who completed treatment titrated to 10 mg bardoxolone methyl in Part 1 were eligible to continue to the extension Part 2 and received bardoxolone methyl 10 mg once-daily from Week 16 and onwards.	0	63	9	63	50	63
EG019	Part 2 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2: Participants who completed bardoxolone methyl matching placebo 10 mg capsules once-daily treatment in Part 1 were eligible to continue to the extension Part 2 and initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from Week 20 and onwards.	0	33	9	33	30	33

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG0030 affected12 at risk EG0040 affected2 at risk EG0050 affected4 at risk EG0060 affected3 at risk EG0070 affected4 at risk EG0080 affected74 at risk EG0090 affected38 at risk EG0100 affected5 at risk EG0111 affected11 at risk EG0120 affected6 at risk EG0130 affected9 at risk EG0140 affected1 at risk EG0150 affected3 at risk EG0160 affected3 at risk EG0170 affected3 at risk EG0180 affected63 at risk EG0190 affected33 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
General physical health deterioration	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Influenza	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Lung infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Salpingitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Urosepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
International normalised ratio increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Delirium	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG0030 affected12 at risk EG0040 affected2 at risk EG0050 affected4 at risk EG0060 affected3 at risk EG0070 affected4 at risk EG0081 affected74 at risk EG0090 affected38 at risk EG0101 affected5 at risk EG0111 affected11 at risk EG0120 affected6 at risk EG0131 affected9 at risk EG0140 affected1 at risk EG0150 affected3 at risk EG0160 affected3 at risk EG0170 affected3 at risk EG0183 affected63 at risk EG0190 affected33 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Splenic vein thrombosis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cardiac discomfort	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Palpitations	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Postural orthostatic tachycardia syndrome	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected12 at risk EG0020 affected11 at risk EG003
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Deafness bilateral	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Meniere's disease	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Cataract	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Keratitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Periorbital oedema	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Retinal tear	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Scleral disorder	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Vision blurred	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0022 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected12 at risk EG0022 affected11 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Painful defaecation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Retching	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Salivary gland enlargement	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Asthenia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Chest discomfort	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Chills	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Fatigue	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Generalised oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Implant site haematoma	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Irritability	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Malaise	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Oedema peripheral	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected12 at risk EG0021 affected11 at risk EG003
Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vessel puncture site haematoma	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vessel puncture site pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vessel puncture site swelling	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gallbladder disorder	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Breast abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Clostridial infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Conjunctivitis infective	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ear infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Folliculitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hordeolum	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Infected cyst	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Influenza	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Laryngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Lung infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Oral herpes	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Otitis externa	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Otitis media	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rhinitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected6 at risk EG0012 affected12 at risk EG0022 affected11 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Viral infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Blood bicarbonate decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Blood creatinine increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Blood potassium decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Blood urine present	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Brain natriuretic peptide increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Cardiac murmur	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cardiac output increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Heart rate increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
International normalised ratio increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Liver function test abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
N-terminal prohormone brain natriuretic peptide increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Platelet count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary arterial pressure increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Serum ferritin decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Venous pressure jugular increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vital capacity abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Weight decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Weight increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
White blood cell count increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0023 affected11 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Folate deficiency	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hyperalbuminaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected12 at risk EG0020 affected11 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0013 affected12 at risk EG0020 affected11 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Clubbing	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0023 affected11 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected12 at risk EG0020 affected11 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected12 at risk EG0021 affected11 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Ageusia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Burning sensation	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Central nervous system lesion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Dizziness exertional	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected12 at risk EG0023 affected11 at risk EG003
Memory impairment	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Migraine	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Multiple sclerosis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Occipital neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Presyncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Sciatica	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Somnolence	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Tremor	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hallucination	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Menstrual disorder	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Vaginal disorder	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected12 at risk EG0022 affected11 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0012 affected12 at risk EG0023 affected11 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0011 affected12 at risk EG0021 affected11 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Mediastinal mass	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pharyngeal lesion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0012 affected12 at risk EG0021 affected11 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Digital ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Menopause	Social circumstances	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Flushing	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0011 affected12 at risk EG0020 affected11 at risk EG003
Hot flush	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0021 affected11 at risk EG003
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected6 at risk EG0010 affected12 at risk EG0020 affected11 at risk EG003

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary
D017563	Lung Diseases, Interstitial
D054988	Idiopathic Interstitial Pneumonias
D054990	Idiopathic Pulmonary Fibrosis
D012507	Sarcoidosis
C562470	Interstitial Pneumonitis, Desquamative, Familial
D018549	Cryptogenic Organizing Pneumonia
D000080203	Hamman-Rich Syndrome

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011658	Pulmonary Fibrosis
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed
D006967	Hypersensitivity
D007154	Immune System Diseases
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D008173	Lung Diseases, Obstructive