Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH... | NCT04170023

ID	Type	Description	Link
2019-003830-17	EudraCT Number

Label	Type	Description	Intervention Names
Open-label ALXN2050 Monotherapy	Experimental	Experimental: Open-label ALXN2050 Monotherapy ALXN2050 orally administered Group 1: Patients with PNH who are treatment naïve Group 2: Patient with PNH who have received complement component 5 (C5) inhibition with eculizumab for at least 6 months, who continue to experience anemia and reticulocytes above the upper limit of normal (ULN) Group 3: Patients with PNH who have received danicopan monotherapy during study ACH471-103	Drug: ALXN2050

Name	Type	Description	Arm Group Labels	Other Names
ALXN2050	Drug	Oral FD inhibitor	Open-label ALXN2050 Monotherapy	ACH-0145228

Measure	Description	Time Frame
Change From Baseline in Hgb at Week 12	Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. To address the impact of transfusion, Hgb values collected within 4 weeks after transfusion were not included in the primary efficacy analysis. Change from Baseline = Hgb at Week 12 - Baseline Hgb.	Baseline, Week 12

Measure	Description	Time Frame
Number of Participants Who Had Transfusion Avoidance During 12 Weeks of Treatment With ALXN2050	Transfusion avoidance: participants remained transfusion-free and did not require a transfusion during the period of interest.	Baseline up to Week 12
Number of Red Blood Cell (RBC) Units Transfused During 12 Weeks of Treatment

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Toronto	Ontario	M5G2C4	Canada
Research Site

PubMed Identifier	Type	Citation	Retractions
41124654	Derived	Kulasekararaj A, Browett P, Risitano AM, Patriquin CJ, Yenerel MN, Marceau D, Sahin F, Algarra JL, Ogawa M, Yu J, Cross NB, Notaro R, Lee JW, Brodsky RA. Efficacy and safety of vemircopan as monotherapy in patients with paroxysmal nocturnal hemoglobinuria. Blood Adv. 2026 Feb 10;10(3):540-554. doi: 10.1182/bloodadvances.2025017731.

Label	URL
Related Info	View source

ID	Title	Description
FG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
FG001	Group 2: Eculizumab Switch

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 7, 2021	Oct 28, 2024

ID	Title	Description
BG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
BG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
BG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Hgb at Week 12

Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. To address the impact of transfusion, Hgb values collected within 4 weeks after transfusion were not included in the primary efficacy analysis. Change from Baseline = Hgb at Week 12 - Baseline Hgb.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

grams/liter

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Units	Counts
Participants	OG00011 OG00110 OG0026

Title

Denominators

Categories

Title	Measurements
	OG00035.6± 14.70 OG00132.5± 20.03 OG002-3.7± 15.77

Secondary

Number of Participants Who Had Transfusion Avoidance During 12 Weeks of Treatment With ALXN2050

Transfusion avoidance: participants remained transfusion-free and did not require a transfusion during the period of interest.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.

Posted

Count of Participants

Participants

Baseline up to Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Secondary

Number of Red Blood Cell (RBC) Units Transfused During 12 Weeks of Treatment

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.

Posted

Mean

Standard Deviation

RBC units

Baseline up to Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Units	Counts

Secondary

Number of Transfusion Instances During 12 Weeks of Treatment

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.

Posted

Mean

Standard Deviation

transfusion instances

Baseline up to Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Units	Counts

Secondary

Change From Baseline in Lactate Dehydrogenase (LDH) at Week 12

Change from Baseline = Serum LDH levels at Week 12 - Baseline Serum LDH levels.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units/liter

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Secondary

Change From Baseline in Absolute Reticulocyte Count at Week 12

Change from Baseline = absolute reticulocyte count at Week 12 - Baseline reticulocyte count.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

10^3 cells/microliter (μL)

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Secondary

Change From Baseline in Direct and Total Bilirubin at Week 12

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for the specified category.

Posted

Mean

Standard Deviation

micromoles (μmol)/liter

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Secondary

Change From Baseline in Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clone Size at Week 12

The PNH RBC clone size refers to the percentage of PNH-affected cells versus normal cells within the total cell population. Change from Baseline = PNH clone size at Week 12 - Baseline PNH clone size.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percentage of the total cell population

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Secondary

Change From Baseline in Component 3 (C3) Fragment Deposition on PNH RBCs at Week 12

C3 fragment deposition on PNH RBC was used as a marker of intra and extravascular hemolysis. Data are presented for the change from baseline to Week 12 in percentage of PNH RBCs with C3 fragment deposition.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percentage of PNH RBC

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading to Discontinuation of Study Medication

An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), or an important medical event or reaction. A TEAE was defined as an AE that emerged during treatment, had been absent prior to treatment, or worsened relative to the pretreatment state. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Safety set included all participants who received at least 1 dose of ALXN2050 in this study.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 217

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
OG001	Group 2: Eculizumab Switch

Secondary

Change From Baseline in Hgb at the End of Treatment (EOT) During the LTE Period

Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. Change from Baseline = Hgb at the EOT visit - Baseline Hgb.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

grams/liter

Baseline, EOT visit (Maximum exposure: 213.4 weeks)

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
OG002	Group 3: Danicopan Rollover

Secondary

Change From Baseline in LDH at the EOT During the LTE Period

Change from Baseline = Serum LDH levels at the EOT visit - Baseline Serum LDH levels.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units/liter

Baseline, EOT visit (Maximum exposure: 213.4 weeks)

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
OG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.

Secondary

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) Total Score at Week 12

The FACIT-Fatigue scale is a collection of quality-of-life questionnaires pertaining to the management of fatigue symptoms due to chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores ranged from 0 to 52, with higher score indicating better quality of life.

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
OG002

Secondary

Change From Baseline in FACIT-Fatigue Scale (Version 4) Total Score at the EOT During the LTE Period

Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline, EOT visit (Maximum exposure: 213.4 weeks)

ID	Title	Description
OG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
OG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Breakthrough haemolysis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0012 affected11 at risk EG0021 affected6 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0014 affected11 at risk EG0020 affected6 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Palpitations	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Episcleritis	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected11 at risk EG0021 affected6 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Enteritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 affected12 at risk EG0012 affected11 at risk EG0021 affected6 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Tongue geographic	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Toothache	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Catheter site rash	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Chills	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0006 affected12 at risk EG0011 affected11 at risk EG0023 affected6 at risk
Influenza like illness	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected11 at risk EG0022 affected6 at risk
Vaccination site pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Jaundice	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Bacterial infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0021 affected6 at risk
Otitis media	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Pulpitis dental	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Rhinitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Tinea cruris	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected11 at risk EG0021 affected6 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected11 at risk EG0021 affected6 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0013 affected11 at risk EG0020 affected6 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Blood creatine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0013 affected11 at risk EG0021 affected6 at risk
International normalised ratio increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Liver function test increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected11 at risk EG0021 affected6 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0014 affected11 at risk EG0022 affected6 at risk
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0006 affected12 at risk EG0013 affected11 at risk EG0021 affected6 at risk
Memory impairment	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Migraine	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Taste disorder	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Chromaturia	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected11 at risk EG0022 affected6 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0014 affected11 at risk EG0022 affected6 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Renal impairment	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0022 affected6 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Intravascular haemolysis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Exudative retinopathy	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Retinal degeneration	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Vitreous floaters	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Chest discomfort	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
General physical health deterioration	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Hyperthermia	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Malaise	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected11 at risk EG0020 affected6 at risk
Non-cardiac chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Oedema	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Oedema peripheral	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected11 at risk EG0022 affected6 at risk
Rebound effect	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Abscess limb	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 affected12 at risk EG0012 affected11 at risk EG0023 affected6 at risk
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Cystitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Ear infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Furuncle	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Onychomycosis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Skin infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Tinea pedis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Tinea versicolour	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0006 affected12 at risk EG0011 affected11 at risk EG0022 affected6 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Blood bicarbonate decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Blood bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Blood creatinine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Cardiac murmur	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Epstein-Barr virus antibody positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Free haemoglobin present	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Hepatic enzyme increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Low density lipoprotein increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Troponin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Weight increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0005 affected12 at risk EG0014 affected11 at risk EG0021 affected6 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Disturbance in attention	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected11 at risk EG0022 affected6 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected11 at risk EG0021 affected6 at risk
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Sleep disorder	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Choluria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Dysuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0021 affected6 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Upper respiratory tract irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected11 at risk EG0020 affected6 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected12 at risk EG0010 affected11 at risk EG0021 affected6 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Flushing	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected11 at risk EG0020 affected6 at risk

ID	Term
D006457	Hemoglobinuria, Paroxysmal
D006461	Hemolysis

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D009190	Myelodysplastic Syndromes
D001855	Bone Marrow Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: Treatment Naive	Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.	12	7	12	12	12
EG001	Group 2: Eculizumab Switch	Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb <10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.	11	5	11	10	11
EG002	Group 3: Danicopan Rollover	Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.	6	2	6	6	6