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 @ 6:56 PM
Ignite Modification Date:
2025-12-25 @ 4:29 PM
NCT ID:
NCT03284957
Description:
Analysis was performed on the safety population.
Frequency Threshold:
5
Time Frame:
Adverse events were collected from first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 232, 96, 59, 11, 130 weeks for Parts A, B, C, D, F, H, I, J respectively. All-cause mortality (deaths) were collected from first dose of study treatment administration (Day 1) to the end of follow-up for death for each participant; up to approximately 372 weeks
Study:
NCT03284957
Study Brief:
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: Amcenestrant 20 mg | Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 1 | None | 0 | 3 | 3 | 3 | View |
| Part A: Amcenestrant 150 mg | Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 1 | None | 1 | 3 | 3 | 3 | View |
| Part A: Amcenestrant 200 mg | Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 1 | 4 | 4 | 4 | View |
| Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 0 | 3 | 3 | 3 | View |
| Part C: Amcenestrant 200 mg + Palbociclib 125 mg | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 1 | None | 2 | 9 | 9 | 9 | View |
| Part C: Amcenestrant 400 mg + Palbociclib 125 mg | Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 1 | 6 | 6 | 6 | View |
| Part A: Amcenestrant 400 mg | Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 0 | 3 | 3 | 3 | View |
| Part H: Amcenestrant 200 mg + Everolimus 5 mg | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 1 | 3 | 3 | 3 | View |
| Part H: Amcenestrant 200 mg + Everolimus 10 mg | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 0 | 3 | 3 | 3 | View |
| Part I: Amcenestrant 200 mg + Everolimus 10 mg | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 1 | 1 | 1 | 1 | View |
| Part A: Amcenestrant 600 mg | Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 1 | None | 1 | 3 | 3 | 3 | View |
| Part A: Amcenestrant 300 mg BID | Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 3 | 6 | 6 | 6 | View |
| Part B: Amcenestrant 400 mg | Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 4 | None | 15 | 49 | 49 | 49 | View |
| Part D: Amcenestrant 200 mg + Palbociclib 125 mg | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 8 | 30 | 29 | 30 | View |
| Part F: Amcenestrant 200 mg + Alpelisib 300 mg | Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 2 | None | 6 | 8 | 8 | 8 | View |
| Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID | Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first. | 0 | None | 1 | 2 | 2 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Cancer Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | View |
| Tumour Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 27.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 27.1 | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 27.1 | View |
| Migraine With Aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Retinal Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 27.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Superior Vena Cava Syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Interstitial Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Duodenal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Large Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Oedema Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 27.1 | View |
| Jaundice Cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 27.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Spinal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Acetabulum Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Humerus Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Breast Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Osteonecrosis Of Jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Pain In Jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Spinal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Temporomandibular Pain And Dysfunction Syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 27.1 | View |
| Micturition Urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 27.1 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 27.1 | View |
| Renal Pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 27.1 | View |
| Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 27.1 | View |
| Urinary Tract Discomfort | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 27.1 | View |
| Breast Mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 27.1 | View |
| Breast Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 27.1 | View |
| Vulvovaginal Dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 27.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Axillary Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Complication Associated With Device | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Face Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Mucosal Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Peripheral Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 27.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Gamma-Glutamyltransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Neutrophil Count Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 27.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Rib Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Thermal Burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Vulvovaginal Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 27.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Memory Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Morton's Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Parkinson's Disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Ectropion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Eye Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Eye Oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Eye Pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Meibomianitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 27.1 | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 27.1 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 27.1 | View |
| Meniere's Disease | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 27.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 27.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 27.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 27.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Hot Flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Jugular Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Subclavian Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Varicose Vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 27.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Lung Infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Sinus Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Upper-Airway Cough Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Anal Erythema | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Anal Incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Aphthous Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Hyperaesthesia Teeth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Intra-Abdominal Haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Oedema Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Teeth Brittle | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 27.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 27.1 | View |
| Hepatic Cytolysis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 27.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Dermatitis Acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Dermatitis Exfoliative Generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Mechanical Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Nail Disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Night Sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Onychoclasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Onychomadesis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Pain Of Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Palmar-Plantar Erythrodysaesthesia Syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Rash Maculo-Papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Rash Pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Skin Fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Skin Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Skin Irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Xeroderma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 27.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Groin Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Joint Swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Musculoskeletal Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 27.1 | View |
| Vulvovaginal Mycotic Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Cancer Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | View |
| Metastases To Central Nervous System | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | View |
| Seborrhoeic Keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | View |
| Skin Papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 27.1 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 27.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 27.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 27.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 27.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 27.1 | View |
| Polydipsia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 27.1 | View |
| Depressed Mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 27.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 27.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 27.1 | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 27.1 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Burning Sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 27.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Escherichia Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Fungal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |
| Viral Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 27.1 | View |