Study of BMS-936558 (Nivolumab) Compared to Docetaxel in... | NCT01673867

NCT01673867

ID	Type	Description	Link
2012-002472-14	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Nivolumab	Experimental	Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.	Biological: Nivolumab
Arm B: Docetaxel	Active Comparator	Docetaxel 75 mg/m^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.	Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological		Arm A: Nivolumab	BMS-936558 (Anti-PD1)
Docetaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint	Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.	Randomization until 413 deaths, up to March 2015 (approximately 29 months)

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men & women ≥18 years of age
Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease
Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent)
Subjects with carcinomatous meningitis
Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior treatment with Docetaxel
Treatment with any investigational agent within 14 days of first administration of study treatment

Other protocol-defined inclusion/exclusion criteria apply

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Scottsdale	Arizona	85259	United States
Local Institution - 0009

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37264091	Derived	Barrera C, Corredor G, Viswanathan VS, Ding R, Toro P, Fu P, Buzzy C, Lu C, Velu P, Zens P, Berezowska S, Belete M, Balli D, Chang H, Baxi V, Syrigos K, Rimm DL, Velcheti V, Schalper K, Romero E, Madabhushi A. Deep computational image analysis of immune cell niches reveals treatment-specific outcome associations in lung cancer. NPJ Precis Oncol. 2023 Jun 1;7(1):52. doi: 10.1038/s41698-023-00403-x.
36897427

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
FG001	Docetaxel

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
BG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
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
	BG00060.9± 9.27 BG00162.3± 9.75 BG00261.6± 9.53

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000141 BG001122 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00019 BG00116 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

Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint

All randomized participants

Posted

Median

95% Confidence Interval

Months

Randomization until 413 deaths, up to March 2015 (approximately 29 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Units	Counts
Participants	OG000292 OG001290

Title

Denominators

Categories

Title	Measurements
	OG00012.19(9.66 to 14.98) OG0019.36(8.05 to 10.68)

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		Log Rank		0.0015		Hazard Ratio (HR)	0.73			2-Sided	95.92	0.59	0.89			HR = Nivolumab over docetaxel		Superiority

Secondary

Objective Response Rate (ORR)

ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization to date of objectively documented progression (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel

Secondary

Time To Objective Response (TTOR)

Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.

All randomized participants who demonstrate partial response (PR) or complete response (CR)

Posted

Median

Full Range

Months

From randomization to the date of first confirmed response (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Secondary

Duration of Objective Response (DOOR)

DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.

All randomized participants who demonstrate partial response (PR) or complete response (CR)

Posted

Median

95% Confidence Interval

Months

From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Secondary

Progression-Free Survival (PFS)

PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Secondary

Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12

Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

Randomization to Week 12

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Secondary

Overall Survival (OS) by PD-L1 Expression at Baseline

Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.

All randomized participants who had a tumor biopsy assessed for PD-L1 expression

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death or last known date alive (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Secondary

Objective Response Rate (ORR) by PD-L1 Expression at Baseline

ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.

All randomized participants who had a tumor biopsy assessed for PD-L1 expression

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization to date of objectively documented progression (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Post-Hoc

Overall Survival (OS) - Extended Collection

Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median computed using Kaplan-Meier method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until December 17, 2021).

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death or last known date alive (up to approximately 110 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
OG001	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

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	Nivolumab 3 mg/kg	Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	258	292	172	287	267	287
EG001	Nivolumab 480 mg	Nivolumab 480 mg solution administered intravenously every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	2	15	5	15	12	15
EG002	Docetaxel	Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	266	290	161	268	258	268
EG003	Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg	Eligible participants from the Docetaxel arm who transitioned to nivolumab 3 mg/kg every 2 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	14	17	9	17	12	17
EG004	Extension Phase of Docetaxel Arm: Nivolumab 480 mg	Eligible participants from the Docetaxel arm who transitioned to nivolumab 480 mg every 4 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.	0	1	1	1	1	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG0030 affected17 at risk EG0040 affected1 at risk
Febrile neutropenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG00224 affected268 at risk EG003
Haematotoxicity	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Leukopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Neutropenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0028 affected268 at risk EG003
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Atrial fibrillation	Cardiac disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Atrial flutter	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Cardiac arrest	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Cardiac failure	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Cardiac tamponade	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Cardiopulmonary failure	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Cardiovascular disorder	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pericardial effusion	Cardiac disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Pericarditis	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Sinus node dysfunction	Cardiac disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Vertigo	Ear and labyrinth disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Adrenal insufficiency	Endocrine disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Retinal tear	Eye disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Abdominal pain	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Ascites	Gastrointestinal disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Colitis	Gastrointestinal disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Constipation	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Diarrhoea	Gastrointestinal disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Dysphagia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Haematemesis	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Inguinal hernia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Intestinal perforation	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Large intestine perforation	Gastrointestinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Nausea	Gastrointestinal disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Stomatitis	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Vomiting	Gastrointestinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Asthenia	General disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Chest pain	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Complication associated with device	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Disease progression	General disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Fatigue	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Gait disturbance	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
General physical health deterioration	General disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Inflammation	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Malaise	General disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Mucosal inflammation	General disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Multiple organ dysfunction syndrome	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Non-cardiac chest pain	General disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Pain	General disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Pyrexia	General disorders	24.1	Systematic Assessment	EG0006 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Sudden death	General disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Cholecystitis	Hepatobiliary disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Cholelithiasis	Hepatobiliary disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Bronchitis	Infections and infestations	24.1	Systematic Assessment	EG0005 affected287 at risk EG0011 affected15 at risk EG0025 affected268 at risk EG003
COVID-19	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Cellulitis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Clostridium difficile colitis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Device related infection	Infections and infestations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Encephalitis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Febrile infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Fungal oesophagitis	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Gastroenteritis norovirus	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Infected skin ulcer	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Infection	Infections and infestations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Lower respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Lung abscess	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Nail infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Osteomyelitis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pneumonia	Infections and infestations	24.1	Systematic Assessment	EG00022 affected287 at risk EG0011 affected15 at risk EG00218 affected268 at risk EG003
Pneumonia bacterial	Infections and infestations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Pneumonia necrotising	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Post procedural pneumonia	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Postoperative wound infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pulmonary sepsis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Sepsis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Septic shock	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Spontaneous bacterial peritonitis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Staphylococcal sepsis	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Upper respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Urinary tract infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Vascular device infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Fall	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Alanine aminotransferase increased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Aspartate aminotransferase increased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Blood creatinine increased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
General physical condition abnormal	Investigations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Neutrophil count decreased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Transaminases increased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
White blood cell count decreased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Dehydration	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0026 affected268 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG00058 affected287 at risk EG0010 affected15 at risk EG00240 affected268 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0005 affected287 at risk EG0010 affected15 at risk EG00210 affected268 at risk EG003
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Carotid artery stenosis	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Central nervous system necrosis	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Cerebrovascular accident	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Depressed level of consciousness	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Epilepsy	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Headache	Nervous system disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Hemiparesis	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Hemiplegia	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Hydrocephalus	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
IVth nerve paresis	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Nervous system disorder	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Neuralgia	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Partial seizures	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Sciatica	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Seizure	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Somnolence	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Spinal cord compression	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Syncope	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Confusional state	Psychiatric disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Depression	Psychiatric disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Disorientation	Psychiatric disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Mental status changes	Psychiatric disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Panic attack	Psychiatric disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Psychotic disorder	Psychiatric disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Acute kidney injury	Renal and urinary disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Haematuria	Renal and urinary disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Renal failure	Renal and urinary disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Urinary retention	Renal and urinary disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00010 affected287 at risk EG0011 affected15 at risk EG0028 affected268 at risk EG003
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00010 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0005 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0012 affected15 at risk EG0021 affected268 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00013 affected287 at risk EG0010 affected15 at risk EG0025 affected268 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00010 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Rash	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Deep vein thrombosis	Vascular disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Embolism	Vascular disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Jugular vein thrombosis	Vascular disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Peripheral artery occlusion	Vascular disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Peripheral artery stenosis	Vascular disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Venous thrombosis	Vascular disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG00037 affected287 at risk EG0010 affected15 at risk EG00268 affected268 at risk EG0030 affected17 at risk EG0040 affected1 at risk
Leukopenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG00229 affected268 at risk EG003
Neutropenia	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG00282 affected268 at risk EG003
Hypothyroidism	Endocrine disorders	24.1	Systematic Assessment	EG00021 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Lacrimation increased	Eye disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG00222 affected268 at risk EG003
Abdominal pain	Gastrointestinal disorders	24.1	Systematic Assessment	EG00019 affected287 at risk EG0010 affected15 at risk EG00216 affected268 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	24.1	Systematic Assessment	EG00011 affected287 at risk EG0010 affected15 at risk EG00214 affected268 at risk EG003
Constipation	Gastrointestinal disorders	24.1	Systematic Assessment	EG00069 affected287 at risk EG0012 affected15 at risk EG00250 affected268 at risk EG003
Diarrhoea	Gastrointestinal disorders	24.1	Systematic Assessment	EG00057 affected287 at risk EG0012 affected15 at risk EG00274 affected268 at risk EG003
Nausea	Gastrointestinal disorders	24.1	Systematic Assessment	EG00072 affected287 at risk EG0012 affected15 at risk EG00285 affected268 at risk EG003
Stomatitis	Gastrointestinal disorders	24.1	Systematic Assessment	EG0008 affected287 at risk EG0010 affected15 at risk EG00224 affected268 at risk EG003
Vomiting	Gastrointestinal disorders	24.1	Systematic Assessment	EG00044 affected287 at risk EG0013 affected15 at risk EG00230 affected268 at risk EG003
Asthenia	General disorders	24.1	Systematic Assessment	EG00060 affected287 at risk EG0011 affected15 at risk EG00263 affected268 at risk EG003
Fatigue	General disorders	24.1	Systematic Assessment	EG00096 affected287 at risk EG0010 affected15 at risk EG002104 affected268 at risk EG003
Mucosal inflammation	General disorders	24.1	Systematic Assessment	EG0006 affected287 at risk EG0010 affected15 at risk EG00219 affected268 at risk EG003
Non-cardiac chest pain	General disorders	24.1	Systematic Assessment	EG00017 affected287 at risk EG0010 affected15 at risk EG00218 affected268 at risk EG003
Oedema peripheral	General disorders	24.1	Systematic Assessment	EG00036 affected287 at risk EG0010 affected15 at risk EG00246 affected268 at risk EG003
Pain	General disorders	24.1	Systematic Assessment	EG00021 affected287 at risk EG0010 affected15 at risk EG00219 affected268 at risk EG003
Pyrexia	General disorders	24.1	Systematic Assessment	EG00037 affected287 at risk EG0010 affected15 at risk EG00244 affected268 at risk EG003
Nasopharyngitis	Infections and infestations	24.1	Systematic Assessment	EG00014 affected287 at risk EG0012 affected15 at risk EG00211 affected268 at risk EG003
Pneumonia	Infections and infestations	24.1	Systematic Assessment	EG0009 affected287 at risk EG0012 affected15 at risk EG00216 affected268 at risk EG003
Upper respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG00019 affected287 at risk EG0011 affected15 at risk EG00213 affected268 at risk EG003
Alanine aminotransferase increased	Investigations	24.1	Systematic Assessment	EG00020 affected287 at risk EG0011 affected15 at risk EG0026 affected268 at risk EG003
Aspartate aminotransferase increased	Investigations	24.1	Systematic Assessment	EG00014 affected287 at risk EG0011 affected15 at risk EG0023 affected268 at risk EG003
Neutrophil count decreased	Investigations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG00218 affected268 at risk EG003
Weight decreased	Investigations	24.1	Systematic Assessment	EG00028 affected287 at risk EG0010 affected15 at risk EG00221 affected268 at risk EG003
White blood cell count decreased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG00222 affected268 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG00091 affected287 at risk EG0010 affected15 at risk EG00264 affected268 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG00015 affected287 at risk EG0010 affected15 at risk EG00215 affected268 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00072 affected287 at risk EG0013 affected15 at risk EG00241 affected268 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00045 affected287 at risk EG0012 affected15 at risk EG00218 affected268 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00018 affected287 at risk EG0010 affected15 at risk EG00214 affected268 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00015 affected287 at risk EG0010 affected15 at risk EG0028 affected268 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00020 affected287 at risk EG0012 affected15 at risk EG00235 affected268 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00029 affected287 at risk EG0011 affected15 at risk EG00230 affected268 at risk EG003
Dizziness	Nervous system disorders	24.1	Systematic Assessment	EG00030 affected287 at risk EG0011 affected15 at risk EG00225 affected268 at risk EG003
Dysgeusia	Nervous system disorders	24.1	Systematic Assessment	EG0006 affected287 at risk EG0010 affected15 at risk EG00220 affected268 at risk EG003
Headache	Nervous system disorders	24.1	Systematic Assessment	EG00033 affected287 at risk EG0011 affected15 at risk EG00235 affected268 at risk EG003
Neuropathy peripheral	Nervous system disorders	24.1	Systematic Assessment	EG00012 affected287 at risk EG0010 affected15 at risk EG00228 affected268 at risk EG003
Paraesthesia	Nervous system disorders	24.1	Systematic Assessment	EG00014 affected287 at risk EG0010 affected15 at risk EG00225 affected268 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	24.1	Systematic Assessment	EG0007 affected287 at risk EG0010 affected15 at risk EG00214 affected268 at risk EG003
Anxiety	Psychiatric disorders	24.1	Systematic Assessment	EG00018 affected287 at risk EG0010 affected15 at risk EG0028 affected268 at risk EG003
Insomnia	Psychiatric disorders	24.1	Systematic Assessment	EG00025 affected287 at risk EG0012 affected15 at risk EG00223 affected268 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00083 affected287 at risk EG0015 affected15 at risk EG00267 affected268 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00068 affected287 at risk EG0011 affected15 at risk EG00264 affected268 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00011 affected287 at risk EG0010 affected15 at risk EG00219 affected268 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00016 affected287 at risk EG0010 affected15 at risk EG00215 affected268 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00014 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00012 affected287 at risk EG0011 affected15 at risk EG00216 affected268 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG00016 affected287 at risk EG0011 affected15 at risk EG00210 affected268 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG00011 affected287 at risk EG0010 affected15 at risk EG00270 affected268 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG00024 affected287 at risk EG0010 affected15 at risk EG0029 affected268 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0007 affected287 at risk EG0011 affected15 at risk EG00218 affected268 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG00037 affected287 at risk EG0011 affected15 at risk EG0027 affected268 at risk EG003
Rash	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG00041 affected287 at risk EG0013 affected15 at risk EG00218 affected268 at risk EG003
Hypertension	Vascular disorders	24.1	Systematic Assessment	EG00014 affected287 at risk EG0012 affected15 at risk EG0024 affected268 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Atrial fibrillation	Cardiac disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Myocardial infarction	Cardiac disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Pericardial effusion	Cardiac disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Tachycardia	Cardiac disorders	24.1	Systematic Assessment	EG0006 affected287 at risk EG0010 affected15 at risk EG0028 affected268 at risk EG003
Ear pain	Ear and labyrinth disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Excessive cerumen production	Ear and labyrinth disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Hypoacusis	Ear and labyrinth disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Hyperthyroidism	Endocrine disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Dyspepsia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0007 affected287 at risk EG0010 affected15 at risk EG00212 affected268 at risk EG003
Dysphagia	Gastrointestinal disorders	24.1	Systematic Assessment	EG0007 affected287 at risk EG0011 affected15 at risk EG0028 affected268 at risk EG003
Chest discomfort	General disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Chest pain	General disorders	24.1	Systematic Assessment	EG00011 affected287 at risk EG0011 affected15 at risk EG0026 affected268 at risk EG003
Influenza like illness	General disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Nodule	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Swelling	General disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Bronchitis	Infections and infestations	24.1	Systematic Assessment	EG00010 affected287 at risk EG0012 affected15 at risk EG0027 affected268 at risk EG003
Campylobacter infection	Infections and infestations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Candida infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0025 affected268 at risk EG003
Conjunctivitis	Infections and infestations	24.1	Systematic Assessment	EG0006 affected287 at risk EG0011 affected15 at risk EG0024 affected268 at risk EG003
Lower respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Oral candidiasis	Infections and infestations	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Respiratory tract infection	Infections and infestations	24.1	Systematic Assessment	EG0005 affected287 at risk EG0010 affected15 at risk EG0023 affected268 at risk EG003
Sinusitis	Infections and infestations	24.1	Systematic Assessment	EG00013 affected287 at risk EG0011 affected15 at risk EG0023 affected268 at risk EG003
Urinary tract infection	Infections and infestations	24.1	Systematic Assessment	EG00013 affected287 at risk EG0010 affected15 at risk EG0029 affected268 at risk EG003
Fall	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0005 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Amylase increased	Investigations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Blood alkaline phosphatase increased	Investigations	24.1	Systematic Assessment	EG0007 affected287 at risk EG0011 affected15 at risk EG0026 affected268 at risk EG003
Blood creatinine increased	Investigations	24.1	Systematic Assessment	EG00011 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Blood glucose increased	Investigations	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0026 affected268 at risk EG003
Blood magnesium decreased	Investigations	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Haemoglobin decreased	Investigations	24.1	Systematic Assessment	EG0005 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Lipase increased	Investigations	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Weight increased	Investigations	24.1	Systematic Assessment	EG00011 affected287 at risk EG0010 affected15 at risk EG0025 affected268 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0026 affected268 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0009 affected287 at risk EG0011 affected15 at risk EG0027 affected268 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG00010 affected287 at risk EG0011 affected15 at risk EG0024 affected268 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	24.1	Systematic Assessment	EG0005 affected287 at risk EG0011 affected15 at risk EG0023 affected268 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG00011 affected287 at risk EG0011 affected15 at risk EG0026 affected268 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0022 affected268 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0008 affected287 at risk EG0011 affected15 at risk EG0024 affected268 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	24.1	Systematic Assessment	EG0003 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Cognitive disorder	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Epilepsy	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0020 affected268 at risk EG003
Hypoaesthesia	Nervous system disorders	24.1	Systematic Assessment	EG00012 affected287 at risk EG0011 affected15 at risk EG0024 affected268 at risk EG003
Memory impairment	Nervous system disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Motor dysfunction	Nervous system disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Transient ischaemic attack	Nervous system disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Confusional state	Psychiatric disorders	24.1	Systematic Assessment	EG00010 affected287 at risk EG0011 affected15 at risk EG0025 affected268 at risk EG003
Depression	Psychiatric disorders	24.1	Systematic Assessment	EG0008 affected287 at risk EG0010 affected15 at risk EG00210 affected268 at risk EG003
Breast pain	Reproductive system and breast disorders	24.1	Systematic Assessment	EG0002 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0007 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0024 affected268 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0004 affected287 at risk EG0010 affected15 at risk EG0022 affected268 at risk EG003
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0009 affected287 at risk EG0011 affected15 at risk EG0025 affected268 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	24.1	Systematic Assessment	EG0000 affected287 at risk EG0010 affected15 at risk EG0021 affected268 at risk EG003
Haematoma	Vascular disorders	24.1	Systematic Assessment	EG0001 affected287 at risk EG0011 affected15 at risk EG0020 affected268 at risk EG003
Hot flush	Vascular disorders	24.1	Systematic Assessment	EG0007 affected287 at risk EG0011 affected15 at risk EG0021 affected268 at risk EG003
Hypotension	Vascular disorders	24.1	Systematic Assessment	EG00012 affected287 at risk EG0011 affected15 at risk EG0029 affected268 at risk EG003

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes