Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
NCT ID:
NCT04936035
Description:
Zilebesiran Treatment Period=Day 1 up to 169 days postdose for zil 150 mg, 300 mg \& 600 mg Q6M; up to 85 days postdose for pbo \& zil 300 mg Q3M regimes. This Set included all participants receiving any of the 4 zil regimens: those taking zil during 6-month placebo-controlled DB (Zil/Zil) \& those switching from pbo to zil after Month 6 (Pbo/Zil). As planned, Zil/Zil arms received same regimen throughout study, so combined AE data are presented for placebo-controlled \& Post 6-Month DB periods.
Frequency Threshold:
5
Time Frame:
6-Month Placebo-controlled DB Period: Day1 up to Month 6; Post-6-Month DB Period: Pbo/Zil arms: From first zilebesiran dose (Month 6) up to Month 36; Zil/ Zil: From first zilebesiran dose (Day 1) up to Month 36 Placebo-controlled DB: Safety Analysis Set=all participants who received any amount of study drug, grouped per treatment received. As planned, AEs were reported for Zilebesiran Treatment Period using All Zilebesiran Treated Set showing data by treatment sequence (Pbo/Zil & Zil/Zil).
Study:
NCT04936035
Study Brief:
A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received zilebesiran matching placebo, as SC injection, Q3M during the 6-month placebo-controlled DB period. | 0 | None | 5 | 75 | 18 | 75 | View |
| Zilebesiran 150 mg Q6M | Participants received zilebesiran, 150 mg, as SC injection on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind. | 0 | None | 0 | 78 | 21 | 78 | View |
| Zilebesiran 300 mg Q6M | Participants received zilebesiran, 300 mg, as SC injection on Day 1 of the 6-month DB period. They received placebo at Month 3 of the 6-month DB period to maintain the blind. | 0 | None | 1 | 73 | 24 | 73 | View |
| Zilebesiran 300 mg Q3M | Participants received zilebesiran, 300 mg, as SC injection, Q3M, during the 6-month placebo-controlled DB period. | 1 | None | 4 | 75 | 23 | 75 | View |
| Zilebesiran 600 mg Q6M | Participants received zilebesiran, 600 mg, as SC injection, on Day 1 of the 6-month placebo-controlled DB period. They received placebo at Month 3 of the 6-month placebo-controlled DB period to maintain the blind. | 0 | None | 6 | 76 | 20 | 76 | View |
| Placebo/Zilebesiran 150 mg Q6M | Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 150 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blind between the Q3M and Q6M regimens. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 0 | None | 1 | 16 | 9 | 16 | View |
| Placebo/Zilebesiran 300 mg Q6M | Participants who received placebo during the 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 0 | None | 0 | 16 | 12 | 16 | View |
| Placebo/Zilebesiran 300 mg Q3M | Participants who received placebo during 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 300 mg, as SC injection Q3M after re-randomization for the remainder of the study. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 0 | None | 1 | 16 | 9 | 16 | View |
| Placebo/Zilebesiran 600 mg Q6M | Participants who received placebo 6-month placebo-controlled DB period were re-randomized at Month 6 to 1 of the 4 initial zilebesiran regimens. Participants in this arm received zilebesiran, 600 mg, as SC injection Q6M after re-randomization for the remainder of the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 0 | None | 0 | 18 | 8 | 18 | View |
| Zilebesiran/Zilebesiran 150 mg Q6M | Participants who received zilebesiran 150 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 1 | None | 5 | 78 | 53 | 78 | View |
| Zilebesiran/Zilebesiran 300 mg Q6M | Participants who received zilebesiran 300 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 0 | None | 5 | 73 | 47 | 73 | View |
| Zilebesiran/Zilebesiran 300 mg Q3M | Participants who received zilebesiran 300 mg Q3M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 1 | None | 7 | 75 | 49 | 75 | View |
| Zilebesiran/ Zilebesiran 600 mg Q6M | Participants who received zilebesiran 600 mg Q6M during the 6-month placebo-controlled DB period remained on the same regimen throughout the study. Participants received placebo at the visit where no zilebesiran dose was planned to maintain blinding between the Q3M and Q6M regimens. Prior to PA6, participants who completed Months 6 to 12 of blinded treatment and pre-dose assessment at Month 12, before a separate OLE study was available, could continue receiving blinded zilebesiran treatment up to additional 24 months in the DB Extension Period. Following PA6, the DB Extension Period was discontinued. Participants who had not yet completed the Month 12 visit at the time of PA6 implementation received their last dose of study drug at Month 9. For participants already in the DB Extension Period at the time of PA6 implementation, dosing depended on scheduled visits: participants whose next visit was at Month 15, 21, 27, or 33 received their planned study drug, while those whose next visit was at Month 18, 24, 30, or 36 did not receive further study drug in the study. | 0 | None | 9 | 76 | 49 | 76 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA26.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Obstructive pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Coronary bypass stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Benign salivary gland neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.0 | View |
| Breast cancer stage II | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.0 | View |
| Malignant melanoma stage III | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.0 | View |
| Paraganglion neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.0 | View |
| Squamous cell carcinoma of the tongue | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Abnormal behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA26.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA26.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Pulmonary infarction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Hypertensive urgency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA26.0 | View |
| Thyroid mass | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA26.0 | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA26.0 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA26.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA26.0 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Coronavirus Disease of 2019 (COVID-19) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Pneumonia mycoplasmal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Brain contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Post-traumatic neck syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Blood creatine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Glycosylated haemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA26.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA26.0 | View |
| Renal cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA26.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA26.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Nasal discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA26.0 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA26.0 | View |