A Study of CIN-107 in Adults With Primary Aldosteronism | NCT04605549 | Trialant
NCT04605549
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Mar 3, 2026Actual
Enrollment
15Actual
Phase
Phase 2
Conditions
Primary Aldosteronism
Hyperaldosteronism
Interventions
CIN-107 2 mg dosing
CIN-107 4 mg dosing
CIN-107 8 mg dosing
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04605549
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CIN-107-122
Secondary IDs
ID
Type
Description
Link
D6970C00001
Other Identifier
AstraZeneca
Brief Title
A Study of CIN-107 in Adults With Primary Aldosteronism
Official Title
A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Effectiveness of CIN-107 for the Management of Blood Pressure in Patients With Primary Aldosteronism
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Feb 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 8, 2021Actual
Primary Completion Date
Oct 28, 2024Actual
Completion Date
Oct 28, 2024Actual
First Submitted Date
Oct 22, 2020
First Submission Date that Met QC Criteria
Oct 22, 2020
First Posted Date
Oct 28, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Oct 27, 2025
Results First Submitted that Met QC Criteria
Feb 11, 2026
Results First Posted Date
Mar 3, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 11, 2026
Last Update Posted Date
Mar 3, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.
Detailed Description
For patients in Part 1 only :
The treatment duration for patients who complete all 3 dose levels, and who opt not to continue in the extension part of the study, is 12 weeks. For patients who do not complete up-titration, the treatment duration will include at least 4 weeks of dosing with the final dose level. If down-titration of CIN-107 dose is determined at Visit 6 (Week 9), the total treatment duration may be extended to 13 weeks to allow sufficient time for CIN-107 treatment effect at the final dose to be assessed. If the final dose of CIN-107 is reached before week 8 (Visit 5) and no up-titration occurs at Visit 5, the patients will be encouraged to continue CIN-107 treatment till Visit 7 for a total of 12 weeks of treatment. The patients who opt not to continue to Part 2 will not receive any study drug and will return for their safety follow up visit (Visit 8) in 2 weeks.
For patients who opt to continue in the extension part (Part 2) of the study:
Patients will continue to receive their dose of baxdrostat and be instructed to measure BP at least once every week prior to dosing with CIN-107 in the morning, during the extension phase. Safety surveillance will be conducted if clinically indicated. Repeat and unscheduled testing for serum potassium may be measured at the investigator's clinical site or at local laboratory for a faster turn-around time to allow clinical assessment. These patients entering part 2 will skip Visit 8 and their next visit will be Visit 9.
Conditions Module
Conditions
Primary Aldosteronism
Hyperaldosteronism
Keywords
Primary Aldosteronism
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
15Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CIN-107 for dosing at 2, 4, or 8 mg (QD)
Experimental
Patients will be provided with an initial dose of CIN-107 and start once daily (QD) dosing of CIN-107 tablets at 2 mg. At Visit 4, CIN-107 dose may be up-titrated to 4 mg QD if the patient has tolerated dosing of CIN-107 at 2 mg and the blood pressure (BP) records indicate minimal hypotension risk.
At Visit 5, CIN-107 dose may be up-titrated to 8 mg QD if the patient has tolerated dosing of CIN-107 at 4 mg.
Drug: CIN-107 2 mg dosing
Drug: CIN-107 4 mg dosing
Drug: CIN-107 8 mg dosing
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CIN-107 2 mg dosing
Drug
One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.
CIN-107 for dosing at 2, 4, or 8 mg (QD)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Treatment Emergent Adverse Events
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
74 weeks
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism
The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism
The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
12 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have been diagnosed with PA.
Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
Are willing to be compliant with the contraception and reproduction restrictions of the study.
Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.
Exclusion Criteria:
At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP > 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.
Have a body mass index > 45 kg/m2.
Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.
Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
Have known documented New York Heart Association class III or IV chronic heart failure.
Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
Have known current severe left ventricular outflow obstruction.
Have had major cardiac surgery within 6 months before the Screening Visit.
Have a history of, or currently experiencing, clinically significant arrhythmias.
Have had a prior solid organ transplant or cell transplant.
Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
Have typical consumption of > 14 alcoholic drinks weekly.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
A total of 33 subjects were screened (signed consent), 15 subjects have been randomized into the study. 15 subjects completed Part 1 of the study and 14 subjects entered Part 2 of the study, 2 of those withdrew, therefore 12 subjects completed Part 2 of the study
Recruitment Details
The study was conducted from 08 March 2021 to 28 October 2024 at 10 sites in United States
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2.
Periods
Title
Milestones
Reasons Not Completed
Part 1 (0 to 12 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 31, 2023
Dec 16, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
CIN-107 4 mg dosing
Drug
Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.
CIN-107 for dosing at 2, 4, or 8 mg (QD)
CIN-107 8 mg dosing
Drug
Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.
CIN-107 for dosing at 2, 4, or 8 mg (QD)
The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg
The percentage of patients achieving a mean seated SBP <140 mmHg and a mean DBP of <90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
12 weeks
The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg
The percentage of patients achieving a mean seated SBP <130 mmHg and a mean DBP of <80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
12 weeks
The Percentage of Patients Achieving the Pharmacodynamic Marker Response
Pharmacodynamic marker response is defined as achieving either: - a plasma aldosterone concentration (PAC) < 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR < 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h
ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2.
Denominators
Units
Counts
Participants
BG00015
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.6± 11.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
Male
BG00010
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
WHITE
Title
Measurements
BG0007
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG000
Region of Enrollment
Number
Participants
Title
Denominators
Categories
USA
Title
Measurements
BG00015
Seated SBP
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG000151.5± 13.46
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Treatment Emergent Adverse Events
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
The Safety Population is defined as all enrolled patients who receive at least one dose of study drug. Due to the small sample size of the study, arms/groups are combined for analysis.
Posted
Number
Number of events
74 weeks
ID
Title
Description
OG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
Units
Counts
Participants
OG00015
Title
Denominators
Categories
Part 1 before titration (0-Week 4)
ParticipantsOG00011
Title
Measurements
OG00027
Part 1 after titration (Week 4-Week 12)
ParticipantsOG000
Primary
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism
The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
ITT Population is defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Posted
Mean
Standard Deviation
mmHg
12 weeks
ID
Title
Description
OG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism
The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Posted
Mean
Standard Deviation
mmHg
12 weeks
ID
Title
Description
OG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
Units
Counts
Participants
OG000
Secondary
The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg
The percentage of patients achieving a mean seated SBP <140 mmHg and a mean DBP of <90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
Units
Counts
Participants
OG000
Secondary
The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg
The percentage of patients achieving a mean seated SBP <130 mmHg and a mean DBP of <80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
Units
Counts
Participants
OG000
Secondary
The Percentage of Patients Achieving the Pharmacodynamic Marker Response
Pharmacodynamic marker response is defined as achieving either: - a plasma aldosterone concentration (PAC) < 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR < 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h
ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
Units
Counts
Participants
OG000
Time Frame
From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
Description
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
All-Cause Mortality Comment
Not provided
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
CIN-107 2 mg Part 1 - Before Titration
CIN-107 at 2 mg (QD) dosing before titration Visit 4 (Week 4) .
0
15
0
15
11
15
EG001
CIN-107 2 mg Part 1 - After Titration
CIN-107 at 2 mg (QD) dosing anytime after titration Week 4 until the end of Part 1.
0
3
0
3
1
3
EG002
CIN-107 4 mg Part 1 - After Titration
CIN-107 at 4 mg (QD) dosing anytime after titration Week 4 until the end of Part 1
0
13
0
13
8
13
EG003
CIN-107 8 mg Part 1 - After Titration
CIN-107 at 8 mg (QD) dosing anytime after titration Week 8 until the end of Part 1
0
8
0
8
2
8
EG004
CIN-107 2 mg Part 2
CIN-107 at 2 mg (QD) dosing anytime during part 2 of the study
0
4
0
4
4
4
EG005
CIN-107 4 mg Part 2
CIN-107 at 4 mg (QD) dosing anytime during part 2 of the study
0
7
0
7
6
7
EG006
CIN-107 8 mg Part 2
CIN-107 at 8 mg (QD) dosing anytime during part 2 of the study
0
7
1
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected7 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected7 at risk
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Vessel puncture site thrombosis
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Pyuria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Extraskeletal ossification
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood potassium increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood pressure increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected13 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood urea increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Lipase abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected13 at risk
EG003
Red cell distribution width increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
White blood cells urine
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Acidosis hyperchloraemic
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected13 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected13 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected13 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected13 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)