Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patien... | NCT03974022

Status Module

Label	Type	Description	Intervention Names
Part A Dose escalation	Experimental		Drug: Sunvozertinib
Part A Dose expansion cohort 1	Experimental		Drug: Sunvozertinib
Part A Dose expansion cohort 2	Experimental		Drug: Sunvozertinib
Part A Dose expansion cohort 3	Experimental	Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy	Drug: Sunvozertinib
Part A Dose expansion cohort 4	Experimental	Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy	Drug: Sunvozertinib
Part A Dose expansion cohort 5	Experimental	Patients with EGFR Exon20ins, treatment naïve	Drug: Sunvozertinib
Part A Dose expansion cohort 6

Name	Type	Description	Arm Group Labels	Other Names
Sunvozertinib	Drug	Daily dose of Sunvozertinib	Part A Dose escalation Part A Dose expansion cohort 1 Part A Dose expansion cohort 2 Part A Dose expansion cohort 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A Dose Escalation: Dose Limiting Toxicities (DLTs).	To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.	The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).
Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).	To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).	through the study completion, an average of around 1 year for part B

Secondary Outcomes

Measure	Description	Time Frame
Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1	To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.	Through the study completion, an average of around 1 year for part B
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged at least 18 years old, be able to provide a signed and dated, written informed consent.
With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.
(ECOG) performance status 0-1.
Predicted life expectancy ≥ 12 weeks
Patient must have measurable disease according to RECIST 1.1.
Patients with brain metastasis (BM) can be enrolled under the condition that BM is previously treated and stable, neurologically asymptomatic and does not require corticosteroid treatment.
Adequate organ system function.
Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve).

Part B Dose extension:
Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from a local CLIA-certified laboratory (or equivalent) or Sponsor designated central laboratory prior to the study entry.
Patients should have received at least 1 line, but no more than 3 lines of systemic therapy for metastatic/locally advanced disease.

Exclusion Criteria:

For part B: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment with currently approved EGFR TKIs for sensitizing or T790M resistance mutations, such as gefitinib, erlotinib, osimertinib, afatinib and dacomitinib, are allowed unless the patient had an objective response and subsequent progression assessed by the investigator.
Treatment with EGFR or HER2 antibodies, major surgery (excluding placement of vascular access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4) within 4 weeks before the first administration of Sunvozertinib.
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before the first administration.
Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before the first administration.
Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A within 1-2 weeks before the first administration.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting Sunvozertinib with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
Spinal cord compression or leptomeningeal metastasis.
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19 (per local practice).
Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs); (2) Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec. (3) Any factors that increase the risk of QTF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval; (4) Prior history of atrial fibrillation within 6 months of first administration of Sunvozertinib, except prior drug treatment related and recovered.
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib.
History of hypersensitivity to active or inactive excipients of Sunvozertinib or drugs with a similar chemical structure or class to Sunvozertinib.
Women who are pregnant or breast feeding.
Involvement in the planning and conduct of the study.
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Name	Affiliation	Role
Pasi Antero Jänne, M.D & Ph. D	Dana-Farber Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego (UCSD) - Moores Cancer Center		La Jolla	California	92093	United States

PubMed Identifier	Type	Citation	Retractions
40923280	Derived	Yang JC, Wang M, Doucet L, Fan Y, Lv D, Sun M, Huang D, Greillier L, Planchard D, Hong Q, Mazieres J, Felip E, Li X, Hu Y, Fang J, Bazhenova L, Ghiringhelli F, Cobo Dols MA, Rodriguez LP, Bearz A, Pellini B, Kim YJ, Bosch-Barrera J, Shim BY, Luo YH, Tiseo M, Yang TY, Carcereny E, Memmott RM, Zalcman G, de Castro Carpeno J, Di Noia V, Parra HS, Streich G, Lee DH, Shum E, Han JY, Jaime JC, Brungs D, John T, D'Arcangelo M, Joaquin AB, Liu G, Antonuzzo L, Hinojal GF, Le X, Zheng L, Janne PA; WU-KONG1B. Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B). J Clin Oncol. 2025 Oct 10;43(29):3198-3208. doi: 10.1200/JCO-25-00788. Epub 2025 Sep 9.
40782807

ID	Title	Description
FG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 24, 2023	Sep 5, 2025

Arm/Group Information

ID	Title	Description
BG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
BG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
BG002	Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
BG003	Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
BG004	Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
BG005	Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State	Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
BG006	Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State	Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
BG007	Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
BG008	Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
BG009	Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal	Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
BG010	Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg	Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
BG011	Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
BG012	Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
BG013	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
BG014	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
BG015	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part A Dose Escalation: Dose Limiting Toxicities (DLTs).

To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib.

DLT was evaluated in the DLT observation frame.

Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis:

Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations.
Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.

Posted

Count of Participants

Participants

The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
OG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
OG002	Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
OG003	Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
OG004	Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.

Units	Counts
Participants	OG0003 OG0015 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).

To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).

Posted

Number

97.5% Confidence Interval

percentage of participants

through the study completion, an average of around 1 year for part B

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized ratio to receive sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants

Secondary

Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1

To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.

Posted

Number

95% Confidence Interval

percentage of participants

Through the study completion, an average of around 1 year for part B

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants	OG000

Secondary

Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1

To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.

Posted

Median

95% Confidence Interval

months

Through the study completion, an average of around 1 year for part B

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants	OG000

Secondary

Part B: AEs/SAEs

To determine the safety and tolerability of Sunvozertinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.

all patients had at least one dose of DZD9008

Posted

Number

participants

Through the study completion, an average of around 1 year for part B

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants

Secondary

Part A: Confirmed ORR and DCR by Investigator.

To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator.

Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period.

Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period.

Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.

Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.

Posted

Number

95% Confidence Interval

percentage of participants

The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
OG001

Secondary

Part A: DoR and PFS by Investigator.

To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator.

DoR was presented for patients with confirmed objective response (CR or PR). DoR was the time from date of first documentation of CR or PR, which was subsequently confirmed, to date of first documentation of objective progression or death. Patients who had no documentation of objective progression or death was censored.

PFS was the time from first dose date of sunvozertinib to date of first documentation of progression or death due to any cause, whichever occurred first. Patient who had no PFS event was censored.

Posted

Median

95% Confidence Interval

month

The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
OG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg

Secondary

Part A: Confirmed ORR and DCR by Independent Review Committee (IRC).

To retrospectively assess anti-tumor activity of sunvozertinib in treatment-naive NSCLC patients with EGFR Exon20ins according to RECIST 1.1 by IRC.

Confirmed ORR was defined as the percentage of patients achieving a CR or PR and was confirmed by subsequent tumor assessment at least 4 weeks within the study period.

Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by subsequent tumor assessment at least 4 weeks within the study period.

Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.

Only participants in Part A were presented here, while Part B were presented separately. According to the clinical study protocol, only participants in Part A Dose Expansion Cohort 5 (treatment-naive patients) were evaluated by IRC. Therefore, we only present the IRC results from Part A Dose Expansion Cohort 5.

Posted

Number

95% Confidence Interval

percentage of participants

The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.

ID	Title	Description
OG000	Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal	Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.

Secondary

Part A Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of DZD9008

Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the single dose.

All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 0 Day 1: 0 (predose) up to 168 hours (for Part A escalation); Cycle 1 Day 1: 0 (predose) up to 24 hours (for Part A expansion)

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
OG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
OG002

Secondary

Part A Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008

Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Cycle 0 Day 1: 0 (predose) up to 168 hours (for Part A escalation); Cycle 1 Day 1: 0 (predose) up to 24 hours (for Part A expansion)

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
OG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.

Secondary

Part A Dose Escalation and Expansion: Cmax,ss, at Steady State of DZD9008

Maximum observed plasma concentration(ng/mL), at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose expansion and expansion)

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
OG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
OG002	Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg

Secondary

Part A Dose Escalation and Expansion: AUCss, at Steady State of DZD9008

Area under the plasma concentration-time curve in the dose interval at steady state, calculated by the linear up/log down rule.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose escalation and expansion)

ID	Title	Description
OG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
OG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
OG002	Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg

Secondary

Part A Food Effect: Maximum Plasma Concentration (Cmax) of DZD9008

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose, in the fasted or fed state.

All participants from the food effect cohort for whom a PK profile is available on at least one of the fed and fasted dosing days.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 1 and Day 9: 0 (predose) up to 168 hours.

ID	Title	Description
OG000	Part A Food Effect Cohort: Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted or High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal or Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants	OG000

Secondary

Part A Food Effect: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008

Area under the plasma concentration-time-curve from time zero the last quantifiable time point, calculated by the linear up/log down rule, in the fasted or fed state.

All participants from the food effect cohort for whom a PK profile is available on at least one of the fed and fasted dosing days.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Day 1 and Day 9: 0 (predose) up to 168 hours.

ID	Title	Description
OG000	Part A Food Effect Cohort: Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted or High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal or Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants	OG000

Secondary

Part B: Maximum Plasma Concentration (Cmax) of DZD9008 and DZ0753

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.

All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 1 Day 1: 0 (predose) up to 24 hours

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.

Units	Counts

Secondary

Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008 and DZ0753.

Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.

All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Cycle 1 Day 1: 0 (predose) up to 24 hours

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.

Units	Counts

Secondary

Part B: Cmax,ss, at Steady State of DZD9008 and DZ0753

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.

All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Cycle 2 Day 1: 0 (predose) up to 24 hours

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants

Secondary

Part B: AUCss, at Steady State of DZD9008 and DZ0753.

Area under the plasma concentration-time curve from time zero in the dose interval at steady state, calculated by the linear up/log down rule.

All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Cycle 2 Day 1: 0 (predose) up to 24 hours

ID	Title	Description
OG000	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
OG001	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.	0	3	0	3	3	3
EG001	Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.	1	6	1	6	6	6
EG002	Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.	0	3	1	3	3	3
EG003	Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.	2	7	4	7	7	7
EG004	Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg	Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.	0	6	2	6	6	6
EG005	Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State	Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.	1	10	4	10	10	10
EG006	Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State	Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.	0	14	5	14	14	14
EG007	Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.	2	14	9	14	14	14
EG008	Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.	1	7	2	7	7	7
EG009	Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal	Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.	4	31	14	31	31	31
EG010	Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg	Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.	0	0	0	0	0	0
EG011	Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.	0	5	0	5	5	5
EG012	Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.	0	7	1	7	7	7
EG013	Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.	33	91	37	91	91	91
EG014	Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.	40	111	41	111	111	111

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG0030 affected7 at risk EG0040 affected6 at risk EG0050 affected10 at risk EG0060 affected14 at risk EG0070 affected14 at risk EG0080 affected7 at risk EG0092 affected31 at risk EG0100 affected0 at risk EG0110 affected5 at risk EG0120 affected7 at risk EG0132 affected91 at risk EG0141 affected111 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Aortic valve stenosis	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Stress cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Anisocoria	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastric polyps	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ileus paralytic	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Intestinal infarction	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pancreatic enzyme abnormality	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Death	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
General physical health deterioration	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Generalised oedema	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pain	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Bile duct stone	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hepatic failure	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Suspected drug-induced liver injury	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Anaphylactic reaction	Immune system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Abscess neck	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Bacteraemia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
COVID-19	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Device related infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Enterobacter sepsis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Escherichia urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hepatitis B reactivation	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Infectious pleural effusion	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Large intestine infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pulmonary tuberculosis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Septic shock	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Suspected COVID-19	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyphaema	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Amylase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blood creatinine increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ejection fraction decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lipase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Neutrophil count decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
White blood cell count decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Nasal neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Aphasia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cubital tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dysarthria	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Haemorrhage intracranial	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Intracranial aneurysm	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Polyneuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Uterine polyp	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin toxicity	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blue toe syndrome	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Venous thrombosis limb	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG0031 affected7 at risk EG0041 affected6 at risk EG0052 affected10 at risk EG0065 affected14 at risk EG0073 affected14 at risk EG0083 affected7 at risk EG0097 affected31 at risk EG0100 affected0 at risk EG0110 affected5 at risk EG0122 affected7 at risk EG01341 affected91 at risk EG01453 affected111 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Bradycardia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cardiac tamponade	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Hypoacusis	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Adrenal insufficiency	Endocrine disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blepharitis	Eye disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cataract	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dry eye	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Glaucoma	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Keratitis	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lacrimation increased	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Presbyopia	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vision blurred	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0020 affected3 at risk EG003
Visual impairment	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vitreous floaters	Eye disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vitreous haemorrhage	Eye disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Angular cheilitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0022 affected3 at risk EG003
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0022 affected3 at risk EG003
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Eructation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastric polyps	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Gingival pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lip dry	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Mouth ulceration	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Tongue ulceration	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Catheter site pain	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Chills	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0002 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Generalised oedema	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Localised oedema	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Mucosal inflammation	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Peripheral swelling	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Swelling	General disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Acarodermatitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Bacteraemia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Bacterial colitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
COVID-19	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Candida infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Carbuncle	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Coronavirus infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cystitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ear infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Folliculitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Herpes simplex reactivation	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hordeolum	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Localised infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Nail infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Paronychia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0021 affected3 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Rash pustular	Infections and infestations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Tinea infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Tinea pedis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Tuberculosis	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vaginal infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Wound infection	Infections and infestations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ear injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Limb injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Amylase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blood bilirubin increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Blood creatinine increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blood lactate dehydrogenase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Blood urea increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
C-reactive protein increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Ejection fraction decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Electrocardiogram QT prolonged	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Fluid balance negative	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Fluid balance positive	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Gamma-glutamyltransferase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lipase increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Lung diffusion test decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Neutrophil count decreased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Platelet count decreased	Investigations	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Prostatic specific antigen increased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Weight decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0013 affected6 at risk EG0020 affected3 at risk EG003
White blood cell count decreased	Investigations	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cachexia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0013 affected6 at risk EG0021 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Metabolic alkalosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0021 affected3 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Aphasia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dementia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Depressed level of consciousness	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0020 affected3 at risk EG003
Dysarthria	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dyskinesia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Hemiparesis	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Meige's syndrome	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Presyncope	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Seizure	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Taste disorder	Nervous system disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Confusional state	Psychiatric disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Micturition urgency	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Proteinuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Penis disorder	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Sexual dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0021 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0022 affected3 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected3 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Papule	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Purpura senile	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Telangiectasia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Cyanosis	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Essential hypertension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected3 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected3 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected3 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases