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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
NCT ID:
NCT03904693
Description:
All-cause mortality: all randomized. SAE/Other AEs: DB: all treated participants. OL: combined safety set was used. Treatment naive participants in both M/T FDC arms (ERA/PDE-5i strata) counted twice per planned analysis. Per plan, for participants treated with M/T FDC in DB, combined data from DB and OL phase collected and analyzed in OL. During OL phase, objective was to analyze safety for M/T FDC irrespective of strata, hence data for combined strata is reported in DB + OL arm, per plan.
Frequency Threshold:
5
Time Frame:
DB: All-cause mortality: From baseline (pre-dose Day 1) to Week 16; SAE and other AEs: From Day 1 to Week 16; OL phase: From Week 16 up to 35 days after last dose (Week 189)
Study:
NCT03904693
Study Brief:
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DB: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC | During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. | 3 | None | 15 | 107 | 72 | 107 | View |
| OL: Treatment-naive and Prior ERA Strata: M/T FDC | After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA and received macitentan monotherapy during DB phase entered open label (OL) phase. During the OL phase participants received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching tadalafil 20 mg, orally, once daily for first 7 days (Week 17, titration phase). Subsequently participants received two tablets of tadalafil 20 mg along with one tablet of macitentan 10 mg, orally, once daily for 7 days (Week 18, titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily. | 0 | None | 10 | 35 | 28 | 35 | View |
| OL: Treatment-naive and Prior PDE-5i Strata: M/T FDC | After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of PDE-5i and received tadalafil monotherapy during DB phase entered OL phase. During the OL phase participants received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for the first 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily. | 2 | None | 13 | 43 | 38 | 43 | View |
| DB + OL: Treatment-naive and Prior ERA/ PDE-5i Strata: M/T FDC | During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i, received macitentan 10 mg along with tadalafil 20 mg and placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. After completion of DB phase, participants who were either treatment-naive or on a predefined stable dose of ERA or PDE-5i and received M/T FDC during DB phase entered OL phase. During the OL phase participants received one tablet macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily for 2 weeks (Week 17 and Week 18; titration phase). From Weeks 19 to 183 (maintenance phase), participants continued to receive one tablet of M/T FDC, orally, once daily. | 9 | None | 39 | 107 | 89 | 107 | View |
| DB: Treatment-naive and Prior ERA Strata: Macitentan Monotherapy 10 Milligrams (mg) | During double-blind (DB) treatment period, participants who were either treatment-naive or on a predefined stable dose of endothelin receptor antagonist (ERA), received one tablet of macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg, orally, once daily at Weeks 1 and 2 (titration phase). From Week 3 to 16 (maintenance phase), participants continued to receive one tablet of macitentan 10 mg and two tablets placebo tablet matching to tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. | 0 | None | 3 | 35 | 16 | 35 | View |
| DB: Treatment-naive And Prior ERA Strata: M/T FDC | During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of ERA, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. | 2 | None | 11 | 70 | 49 | 70 | View |
| DB: Treatment-naive And Prior PDE-5i Strata: Tadalafil Monotherapy 20 mg (2 Tablets*20 mg) | During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of phosphodiesterase type-5 inhibitor (PDE-5i), received one tablet (two tablets if already on allowable dose at baseline) of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (titration phase). Participants further received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg, orally, once daily at Week 2 (titration phase). From Week 3 to 16 (maintenance phase), participants received two tablets of tadalafil 20 mg along with one tablet of placebo matching to macitentan 10 mg and one tablet of placebo matching to M/T FDC, orally, once daily. | 0 | None | 4 | 44 | 31 | 44 | View |
| DB: Treatment-naive And Prior PDE-5i Strata: M/T FDC | During DB treatment period, participants who were either treatment-naive or on a predefined stable dose of PDE-5i, received one tablet of macitentan 10 mg along with one tablet of tadalafil 20 mg and one tablet of placebo matching to tadalafil 20 mg, orally, once daily at Week 1 (uptitration phase). Participants further received one tablet of macitentan 10 mg along with two tablets of tadalafil 20 mg, orally, once daily at Week 2 (uptitration phase). From Week 3 to 16 (maintenance phase), participants received one tablet of placebo matching to macitentan 10 mg along with two tablets of placebo matching to tadalafil 20 mg and one tablet of macitentan 10 mg and tadalafil 40 mg fixed-dose combination (M/T FDC), orally, once daily. | 2 | None | 12 | 86 | 58 | 86 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| Normochromic Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Atrial Flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Cor Pulmonale | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Left Ventricular Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Right Ventricular Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Sinus Node Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Supraventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Retinal Vein Occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 25.1 | View |
| Colitis Ischaemic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Haemorrhoidal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Hiatus Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Large Intestine Polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Oesophageal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Subileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Tongue Cyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Upper Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Varices Oesophageal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Swelling Face | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Hepatic Cirrhosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| Portal Hypertension | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| Abscess Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Covid-19 Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Gastroenteritis Clostridial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Parainfluenzae Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Pneumonia Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Rhinovirus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Staphylococcal Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| Humerus Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| Jaw Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| Patella Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| Subdural Haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Greater Trochanteric Pain Syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Intervertebral Disc Protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Systemic Scleroderma | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Basal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| Breast Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| Mucinous Cystadenocarcinoma Ovary | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| Prostate Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| Cerebral Infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Horner's Syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| Glomerulonephritis Membranous | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| Renal Impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| Endometrial Hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.1 | View |
| Endometriosis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.1 | View |
| Intermenstrual Bleeding | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.1 | View |
| Ovarian Cyst Ruptured | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.1 | View |
| Uterine Polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.1 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Autoimmune Lung Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Pulmonary Arterial Hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Pulmonary Veno-Occlusive Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| Iron Deficiency Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Suspected Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| Haemoglobin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Intervertebral Disc Protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| Breast Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |