Adverse Events Module

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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 @ 11:19 PM
Ignite Modification Date: 2025-12-25 @ 9:01 PM
NCT ID: NCT01822756
Description: Safety population included all enrolled subjects who received at least 1 dose of RUX.
Frequency Threshold: 0
Time Frame: From randomization to 30 days after last visit up to approximately 6 months.
Study: NCT01822756
Study Brief: An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A0 RUX 15 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 None None 10 16 16 16 View
Cohort B (-1) RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15; + GCSF None None 4 4 4 4 View
Cohort B0 (+GCSF) RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; +GCSF None None 3 10 10 10 View
Cohort B0 (-GCSF) RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; -GCSF None None 0 4 4 4 View
Cohort B1 RUX 10 mg BID; Gemcitabine 1000 mg/m\^2; nab-Paclitaxel 100 mg/m\^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19 None None 2 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Duodenal ulcer hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Eye infection toxoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pharyngeal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pneumocystis jiroveci pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Haemobilia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Malignant ascites SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Increased tendency to bruise SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Ear congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Portal hypertensive gastropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Varices oesophageal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Catheter site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Cardiac enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Lower extremity mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Colonic Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Blood iron decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View