Safety and Efficacy Study of Ravulizumab in Adults With G... | NCT03920293

ID	Type	Description	Link
2018-003243-39	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ravulizumab	Experimental	Participants will receive ravulizumab for the duration of the study.	Biological: Ravulizumab
Placebo	Placebo Comparator	Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ravulizumab	Biological	Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26	The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.	Baseline, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26	The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona	85013	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38319212	Derived	Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, Enayetallah A, Beasley KN, Rampal N, Howard JF. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. NEJM Evid. 2022 May;1(5):EVIDoa2100066. doi: 10.1056/EVIDoa2100066. Epub 2022 Apr 26.
37103755	Derived	Meisel A, Annane D, Vu T, Mantegazza R, Katsuno M, Aguzzi R, Frick G, Gault L, Howard JF Jr; CHAMPION MG Study Group. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023 Aug;270(8):3862-3875. doi: 10.1007/s00415-023-11699-x. Epub 2023 Apr 27.

Label	URL
Related Info	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ravulizumab to Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 25, 2019	May 3, 2022

Arm/Group Information

ID	Title	Description
BG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
BG001	Placebo	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.0± 13.82 BG00153.3± 16.05 BG00255.6± 15.14

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00044 BG00145 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0015 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

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 Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26

The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 26

ID	Title	Description
OG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
OG001	Placebo	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.

Units	Counts
Participants	OG00086 OG00189

Title

Denominators

Categories

Title	Measurements
	OG000-3.1± 0.38 OG001-1.4± 0.37

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		=0.0009	Statistical significance was tested at α=0.05.	LS Mean Difference	-1.6	Standard Error of the Mean	0.49	2-Sided	95	-2.6	-0.7					Superiority

Secondary

Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26

The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 26

ID	Title	Description
OG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
OG001	Placebo	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.

Secondary

Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26

The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. A decrease in score indicated improvement. Percentage of participants with a ≥5-point reduction in the QMG total score are reported. Estimates were based on a generalized linear mixed model (GLMM) that included treatment group, stratification factor region and QMG total score at baseline, study visit and study visit by treatment group interaction.

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
OG001	Placebo	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.

Secondary

Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26

The revised Myasthenia Gravis Qualify of Life 15-item scale (MG-QOL15r) is a health-related QoL evaluative instrument specific to participants with MG. The MG-QOL15r was designed to provide information about participants' perception of impairment and disability, determine the degree to which disease manifestations are tolerated, and to be administered and interpreted easily. Each item was graded on a scale of 0 to 2, with 2 being the most severe. The range of MG-QOL15r score is 0 to 30. Higher scores indicated greater extent of and dissatisfaction with MG-related dysfunction. Estimates are based on MMRM that included treatment group, stratification factor region and MG-QOL15r score at baseline, study visit and study visit by treatment group interaction.

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Week 26

ID	Title	Description
OG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
OG001	Placebo

Secondary

Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26

The Neuro-QOL Fatigue is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each items was rated on a scale of 1 to 5, with 5 being the most severe. The range of total score is 19 to 95. Higher scores indicated greater fatigue and greater impact of MG on activities. Estimates were based on MMRM that included treatment group, stratification factor region and Neuro-QoL Fatigue score at baseline, study visit, and study visit by treatment group interaction.

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 26

ID	Title	Description
OG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.
OG001	Placebo	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.

Secondary

Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26

The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Percentage of participants with a ≥3-point reduction in the MG-ADL total score are reported. Estimates were based on a GLMM that included treatment group, stratification factor region and MG-ADL total score at baseline, study visit and study visit by treatment group interaction.

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized-Controlled Period: Ravulizumab	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.	2	86	20	86	77	86
EG001	Randomized-Controlled Period: Placebo	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.	0	89	14	89	75	89
EG002	Open-Label Extension Period: Placebo to Ravulizumab	After the randomized-controlled part of the study, participants in the placebo group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	3	83	32	83	79	83
EG003	Open-Label Extension Period: Ravulizumab to Ravulizumab	After the randomized-controlled part of the study, participants in the ravulizumab group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.	3	78	24	78	77	78

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected86 at risk EG0010 events0 affected89 at risk EG0022 events2 affected83 at risk EG0030 events0 affected78 at risk
Arthritis bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Gangrene	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0024 events2 affected83 at risk EG003
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0012 events2 affected89 at risk EG0022 events2 affected83 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Myasthenia gravis crisis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Facial paresis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0013 events3 affected89 at risk EG0022 events1 affected83 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Nodal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
General physical health deterioration	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Ureteral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Visual impairment	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Infusion-related reaction	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Granuloma skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected89 at risk EG0020 events0 affected83 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0022 events2 affected83 at risk EG003
Erysipelas	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Anal abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Gonococcal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Localised infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Meningitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Neisseria infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0022 events2 affected83 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Mitral valve stenosis	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Prinzmetal angina	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0022 events2 affected83 at risk EG003
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Death	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Acute psychosis	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Depression	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Pancreatic cystadenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Vein rupture	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Cataract	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0020 events0 affected83 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected86 at risk EG0013 events3 affected89 at risk EG00228 events26 affected83 at risk EG00332 events30 affected78 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 events5 affected86 at risk EG0015 events4 affected89 at risk EG00213 events8 affected83 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected86 at risk EG0017 events5 affected89 at risk EG00218 events11 affected83 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00014 events13 affected86 at risk EG00115 events11 affected89 at risk EG00212 events10 affected83 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00012 events9 affected86 at risk EG00110 events9 affected89 at risk EG00218 events9 affected83 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0006 events5 affected86 at risk EG0010 events0 affected89 at risk EG0025 events4 affected83 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00019 events16 affected86 at risk EG00127 events23 affected89 at risk EG00221 events17 affected83 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0009 events8 affected86 at risk EG0013 events3 affected89 at risk EG00210 events6 affected83 at risk EG003
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0007 events6 affected86 at risk EG0016 events6 affected89 at risk EG0027 events6 affected83 at risk EG003
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected86 at risk EG0016 events5 affected89 at risk EG0025 events5 affected83 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected86 at risk EG0015 events5 affected89 at risk EG00210 events10 affected83 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0008 events6 affected86 at risk EG0018 events7 affected89 at risk EG00215 events9 affected83 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0029 events9 affected83 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0024 events4 affected83 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0025 events5 affected83 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0025 events5 affected83 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0025 events5 affected83 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0022 events2 affected83 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0025 events5 affected83 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0023 events3 affected83 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0026 events5 affected83 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG00211 events10 affected83 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0026 events6 affected83 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0021 events1 affected83 at risk EG003
Depression	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0028 events7 affected83 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected89 at risk EG0027 events5 affected83 at risk EG003

Ancestor Terms

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010257	Paraneoplastic Syndromes
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D020511	Neuromuscular Junction Diseases
D009468	Neuromuscular Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases