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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT01478594
Description: None
Frequency Threshold: 5
Time Frame: From the first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib arm and 162.0 days in the bevacizumab arm.
Study: NCT01478594
Study Brief: A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tivozanib + mFOLFOX6 Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle. None None 82 177 175 177 View
Bevacizumab + mFOLFOX6 Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle. None None 42 87 85 87 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Anal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pneumatosis intestinalis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Perihepatic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Enterocolitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Device malfunction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Stent malfunction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Subclavian vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Aortic valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Intracardiac thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Reversible posterior leukoencephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Monoparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatic haemorrhage SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Angiomyolipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Duodenal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Wound necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Anorectal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Chemotherapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Vaginal fistula SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View