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 @ 9:55 PM
Ignite Modification Date: 2025-12-25 @ 7:33 PM
NCT ID: NCT02508532
Description: None
Frequency Threshold: 5
Time Frame: For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
Study: NCT02508532
Study Brief: (NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory 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
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. 4 None 5 6 6 6 View
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. 1 None 3 3 3 3 View
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation. 111 None 140 217 214 217 View
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. 0 None 3 6 6 6 View
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. 4 None 4 6 6 6 View
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. 2 None 5 6 5 6 View
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. 3 None 5 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cyst rupture SYSTEMATIC_ASSESSMENT General disorders MedRA View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Tumour rupture SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Circumoral oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Gastroduodenal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Gastrointestinal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Intestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Oesophagitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Herpes simplex encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Infected cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Pneumonia escherichia SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Spinal cord infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedRA View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedRA View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedRA View
Haemorrhagic cyst SYSTEMATIC_ASSESSMENT General disorders MedRA View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedRA View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Central nervous system lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dementia with Lewy bodies SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Restrictive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Benign gastric neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Leiomyosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Metastases to perineum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Metastases to peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Oesophageal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedRA View
Fistula discharge SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedRA View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedRA View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedRA View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View
Adrenal haemorrhage SYSTEMATIC_ASSESSMENT Endocrine disorders MedRA View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Hair colour changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View