Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:59 AM
NCT ID: NCT03125902
Description: None
Frequency Threshold: 5
Time Frame: From baseline up to 64 months
Study: NCT03125902
Study Brief: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atezolizumab + Paclitaxel Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. 229 None 112 431 421 431 View
Placebo + Paclitaxel Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. 119 None 40 220 209 220 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
BICYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
LYMPHADENITIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
PERICARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.1 View
HYPOPHYSITIS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
KERATITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.1 View
ORBITAL MYOSITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.1 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
COLITIS ULCERATIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
GASTROINTESTINAL ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
IMMUNE-MEDIATED PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
MULTIPLE ORGAN DYSFUNCTION SYNDROME SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
HEPATITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
ANAPHYLACTIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.1 View
DRUG HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
DEVICE RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
DIARRHOEA INFECTIOUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
ERYSIPELAS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
PNEUMOCYSTIS JIROVECII PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
PULMONARY SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
VASCULAR DEVICE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
VESTIBULAR NEURONITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
INFUSION RELATED REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
PROCEDURAL PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
TRANSAMINASES INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
HYPERAMYLASAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
HYPERLIPASAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
HYPOPROTEINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
PATHOLOGICAL FRACTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
POLYMYOSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
TUMOUR PAIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.1 View
CEREBRAL VENOUS SINUS THROMBOSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
COGNITIVE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
MYASTHENIA GRAVIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
DEVICE BREAKAGE SYSTEMATIC_ASSESSMENT Product Issues MedDRA 25.1 View
DEVICE KINK SYSTEMATIC_ASSESSMENT Product Issues MedDRA 25.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
GLOMERULONEPHRITIS CHRONIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
NEPHRITIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
RENAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
INTERSTITIAL LUNG DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
LUNG DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
RESPIRATORY DISTRESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
HAEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
MYELOSUPPRESSION SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
VENTRICULAR ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
AUTOIMMUNE PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
FIBULA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
SKIN LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
COMPLETED SUICIDE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
HYPOMANIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
EMBOLISM VENOUS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
SOFT TISSUE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
STAPHYLOCOCCAL SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
UROSEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
HEPATIC FUNCTION ABNORMAL SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
MYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
POSTOPERATIVE WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
NEUROPATHY PERIPHERAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.1 View
BREAST PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View