Study to Assess the Safety, Tolerability, Efficacy and PK... | NCT03226678

Label	Type	Description	Intervention Names
270mg or 360mg APL-2 administered subcutaneously daily (CAD)	Experimental		Drug: APL-2
270mg or 360mg APL-2 administered subcutaneously daily (wAIHA)	Experimental		Drug: APL-2

Name	Type	Description	Arm Group Labels	Other Names
APL-2	Drug	Complement (C3) Inhibitor	270mg or 360mg APL-2 administered subcutaneously daily (CAD) 270mg or 360mg APL-2 administered subcutaneously daily (wAIHA)

Measure	Description	Time Frame
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity	TEAEs were defined as adverse events (AEs) that occurred after dosing on Day 1 and up to 56 days after the last dose of study drug. A treatment-related TEAE is defined as a TEAE with a relationship to study drug of probably, possibly, unlikely, or unrelated. A serious adverse event (SAE) is defined as any AE that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; was a congenital anomaly or birth defect. TEAEs were graded according to Common Terminology Criteria for Adverse Events v4.03 based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.	Part A:From first dose of study drug (Part A Day 1) up to 30days after last dose of study drug in Part A,approximately 366days Part B:From first dose of study drug (Part B Day 1) up to 56days after last dose of study drug in Part B,approximately 980days

Measure	Description	Time Frame
Mean Change From Baseline in Hemoglobin at Weeks 48 and 132	Hematology assessments of hemoglobin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in hemoglobin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age.
Weight < 125 Kg.
Subjects must have a primary diagnosis of wAIHA or CAD defined by the presence of hemolytic anemia and positive DAT for wAIHA (IgG) or CAD (C3).
Hemoglobin <11 g/dL.
Signs of hemolysis with abnormal values by any of the hemolytic markers:
1. Increased absolute reticulocyte count (above ULN)
2. Reduced haptoglobin (below LLN)
3. Increased lactase dehydrogenase (LDH) (above ULN)
4. Increased indirect bilirubin (above ULN)
Women of child-bearing potential (WOCBP) (defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause) must have a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and 60 days after their last dose of study drug.
Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and 60 days after their last dose of study drug.
Able to provide documentary evidence of the following vaccinations within 2 years prior to screening:
1. Neisseria meningitides types A, C, W, Y and type B (administered as two separate vaccinations)
2. Streptococcus pneumoniae (Pneumococcal conjugate vaccine and Pneumococcal polysaccharide vaccine 23 [PCV13 and/or PPSV23, respectively])
3. Haemophilus influenzae Type B (Hib) vaccine
Subjects that do not have documentary evidence must be willing to receive any missing vaccinations as outlined below:
1. Neisseria meningitides types A, C, W, Y and type B must be administered prior to dosing on Day 1. A booster is administered after at least 8 weeks (Day 56; for both vaccinations).
2. Streptococcus pneumoniae PCV13 must be administered prior to dosing on Day 1 (see Section 12.2 for details). A PPSV23 booster is administered after at least 8 weeks (Day 56)
3. Haemophilus influenze Type B (Hib) must be administered prior to dosing on Day 1.
Willing and able to give informed consent.
Specific for wAIHA: Relapsed from, did not respond or relapsed, or did not tolerate, at least one prior wAIHA treatment regimen (such as prednisone, rituximab).

Exclusion Criteria:

Prior treatment with rituximab within 90 days.
Deficiency of iron, folic acid and vitamin B12 prior to treatment phase
Abnormal liver function as indicated by a direct bilirubin above normal level, and/or an AST or ALT level > 2x upper limit of normal. Please note elevated indirect bilirubin due to hemolysis is not an exclusion criteria.
Elevated bilirubin not due to active hemolysis. Any elevation of bilirubin >ULN will require Sponsor review and approval for subject enrollment into the trial.
Active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or carcinoma in situ (CIS) of the cervix.
Presence or suspicion of active bacterial or viral infection, in the opinion of the Investigator, at screening or severe recurrent bacterial infections.
Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period.
Pregnant, breast-feeding, or intending to conceive during the course of the study, including the Post-Treatment Phase.
Inability to cooperate or any condition that, in the opinion of the investigator, could increase the subject's risk by participating in the study or confound the outcome of the study.
Myocardial infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months or > Class 2 Angina Pectoris or NYHA Heart Failure Class >2
QTcF > 470 ms
PR > 280 ms
Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities

Facility	Status	City	State	ZIP	Country	Contacts
American Institute of Research		Whittier	California	90603	United States
Lakes Research

PubMed Identifier	Type	Citation	Retractions
39486046	Derived	Roman E, Fattizzo B, Shum M, Hanna W, Lentz SR, Araujo SSS, Al-Adhami M, Grossi FV, Gertz MA. Safety and efficacy of pegcetacoplan treatment for cold agglutinin disease and warm antibody autoimmune hemolytic anemia. Blood. 2025 Jan 23;145(4):397-408. doi: 10.1182/blood.2023022549.

ID	Title	Description
FG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 milligram (mg) per day subcutaneous (SC) infusion up to 12 months in Part A.
FG001	Part A: Cohort 1 wAIHA - 360 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 17, 2019	Oct 25, 2023

ID	Title	Description
BG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
BG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
BG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
BG003	Part A: Cohort 2 CAD - 360 mg	Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG0016 BG0027 BG0036 BG00424

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

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity

TEAEs were defined as adverse events (AEs) that occurred after dosing on Day 1 and up to 56 days after the last dose of study drug. A treatment-related TEAE is defined as a TEAE with a relationship to study drug of probably, possibly, unlikely, or unrelated. A serious adverse event (SAE) is defined as any AE that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; was a congenital anomaly or birth defect. TEAEs were graded according to Common Terminology Criteria for Adverse Events v4.03 based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.

The Safety set included all subjects who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Part A:From first dose of study drug (Part A Day 1) up to 30days after last dose of study drug in Part A,approximately 366days Part B:From first dose of study drug (Part B Day 1) up to 56days after last dose of study drug in Part B,approximately 980days

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
OG003	Part A: Cohort 2 CAD - 360 mg	Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG004	Part B: Cohort 1 wAIHA - 1080 mg	Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
OG005	Part B: Cohort 2 CAD - 1080 mg	Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.

Units	Counts
Participants	OG0005 OG0016 OG0027 OG003

Title

Denominators

Categories

All TEAEs

Title	Measurements
	OG0005 OG0015 OG0027 OG003

Secondary

Mean Change From Baseline in Hemoglobin at Weeks 48 and 132

Hematology assessments of hemoglobin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in hemoglobin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The intent-to-treat (ITT) analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

gram per deciliter (g/dL)

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.

Secondary

Number of Subjects Who Received Red Blood Cell (RBC) Transfusions

The number of on-study RBC transfusions were monitored throughout the treatment period.

The ITT analysis set included all subjects who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

From Day 1 up to Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
OG003	Part A: Cohort 2 CAD - 360 mg	Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.

Secondary

Mean Change From Baseline in Absolute Reticulocyte Count (ARC) at Weeks 48 and 132

Hematology assessments of ARC were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in ARC results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

10^9 cells/liter (L)

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.

Secondary

Mean Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 48 and 132

Serum chemistry assessments of LDH were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in LDH results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

international units/L

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.

Secondary

Mean Change From Baseline in Haptoglobin at Weeks 48 and 132

Serum chemistry assessments of haptoglobin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in haptoglobin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

g/L

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.

Secondary

Mean Change From Baseline in Indirect Bilirubin at Weeks 48 and 132

Serum chemistry assessments of indirect bilirubin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in indirect bilirubin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

micromole/L

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.

Secondary

Maximum Observed Trough Serum Concentration (Ctrough,Max) of Pegcetacoplan

Blood samples were collected for the assessment of Ctrough,max of pegcetacoplan.

The Pharmacokinetic analysis set included all subjects in the Safety set who had at least 1 evaluable post-dose pharmacokinetic measurement that was not below the limit of quantification.

Posted

Mean

Standard Deviation

microgram per milliliter

Pre-dose and 4 hours postdose on Day 1; pre-dose on Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120 and 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
OG003	Part A: Cohort 2 CAD - 360 mg

Secondary

Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 48 and 132

The FACIT-Fatigue Scale is a 13 item Likert scaled instrument where the subject was presented with 13 statements and asked to indicate their response as it applied to the past 7 days. The 5 possible responses were 'Not at all' (0), 'A little bit (1), 'Somewhat' (2), 'Quite a bit' (3) and 'Very much' (4). There are 13 statements with the total score ranging from 0 to 52 and higher scores indicating better quality of life. Mean change from baseline in FACIT-Fatigue score results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

score on a scale

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
OG002

Secondary

Mean Change From Baseline in Linear Analog Scale Assessment (LASA) Score at Weeks 48 and 132

The LASA consists of 5 single statements asking subjects to rate their perceived level of functioning. Specific domains include physical well-being (fatigue, activity level), emotional well-being (depression, anxiety, stress), spiritual well-being (sense of meaning), and intellectual well-being (ability to think clearly and concentrate). An item for overall quality of life is also included. Each domain scale range from 0 to 10. Where, 0 = as bad as it can be and 10 = as good as it can be. The total score ranging from 0 to 50 and higher scores indicating better quality of life. Mean change from baseline in LASA score results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.

The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.

Posted

Mean

Standard Deviation

score on a scale

Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132

ID	Title	Description
OG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
OG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG0030 affected6 at risk EG004
Haemolysis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Blood calcium increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Generalised anxiety disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0012 affected6 at risk EG0020 affected7 at risk EG0030 affected6 at risk EG0041 affected5 at risk EG0052 affected9 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Extravascular haemolysis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Cyanosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Goitre	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Eye irritation	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Ocular hypertension	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0022 affected7 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0010 affected6 at risk EG0024 affected7 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0010 affected6 at risk EG0022 affected7 at risk EG003
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0022 affected7 at risk EG003
Infusion site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Infusion site rash	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Injection site bruising	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Injection site erythema	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Injection site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Injection site pruritus	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Injection site reaction	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Injection site swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Local swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0012 affected6 at risk EG0021 affected7 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Candida infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Ear infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Fungal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Incision site abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Mastitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0022 affected7 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pseudophakic bullous keratopathy	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Blood glucose abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
White blood cell count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0022 affected7 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Folate deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Vitamin B complex deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0011 affected6 at risk EG0023 affected7 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0022 affected7 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Sinonasal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0023 affected7 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Migraine	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0022 affected7 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Agitation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Generalised anxiety disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Renal injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Breast fibrosis	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0021 affected7 at risk EG003
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Skin warm	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Venous ulcer pain	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Flushing	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Leriche syndrome	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Pallor	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Spider vein	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected5 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Cohort 1 wAIHA - 270 mg	Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.	0	5	3	5	5	5
EG001	Part A: Cohort 1 wAIHA - 360 mg	Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.	0	6	2	6	5	6
EG002	Part A: Cohort 2 CAD - 270 mg	Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.	1	7	3	7	7	7
EG003	Part A: Cohort 2 CAD - 360 mg	Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.	0	6	2	6	6	6
EG004	Part B: Cohort 1 wAIHA - 1080 mg	Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.	0	5	2	5	5	5
EG005	Part B: Cohort 2 CAD - 1080 mg	Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.	1	9	6	9	9	9