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: 2025-12-25 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:45 AM
NCT ID: NCT02501902
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 5
Time Frame: From the signing of informed consent up to 56 days after the last administration of the investigational product, or 365 days from the first dose of investigational product, whichever is later.
Study: NCT02501902
Study Brief: Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DL1 Palbociclib 75mg / Nab-Paclitaxel 100mg/m^2 Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the starting dose level (DL), participants received palbociclib 75 milligrams (mg) daily for 3 weeks of each 28-day cycle and nab-P 100 milligrams per square miter (mg/m\^2) weekly for 3 weeks out of each 28-day cycle. 0 None 2 3 3 3 View
DL2A Palbociclib 100mg / Nab-Paclitaxel 100mg/m^2 Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2A, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m\^2 weekly for 3 weeks out of each 28-day cycle. 1 None 4 7 7 7 View
DL2B Palbociclib 75mg / Nab-Paclitaxel 125mg/m^2 Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 2B, participants received palbociclib 75mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m\^2 weekly for 3 weeks out of each 28-day cycle. 3 None 3 4 4 4 View
DL3A Palbociclib 125mg / Nab-Paclitaxel 100mg/m^2 Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3A, participants received palbociclib 125mg daily for 3 weeks of each 28-day cycle and nab-P 100mg/m\^2 weekly for 3 weeks out of each 28-day cycle. 2 None 4 11 11 11 View
DL3B Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2 Consecutive cohorts of participants received escalating doses of oral palbociclib in combination with intravenous nab-P in 28-day cycles. This was the escalated DL 3B, participants received palbociclib 100mg daily for 3 weeks of each 28-day cycle and nab-P 125mg/m\^2 weekly for 3 weeks out of each 28-day cycle. 3 None 6 11 10 11 View
MDR1 Palbociclib 75mg/Nab-Paclitaxel 125mg/m^2 This was the modified dose regimen 1 (MDR1), participants received palbociclib 75mg once daily on Days 1-21 of each 28-day cycle, plus nab-P 125mg/m\^2 biweekly in each 28-day cycle. 5 None 9 11 11 11 View
MDR2 Palbociclib 75mg/Nab-Paclitaxel 100mg/m^2 This was the MDR2, participants received palbociclib 75mg continuous dosing, once daily, plus nab-P 100mg/m\^2 biweekly in each 28-day cycle. 2 None 2 9 9 9 View
MTD Palbociclib 100mg/Nab-Paclitaxel 125mg/m^2 The estimated maximum tolerated dose (MTD) was the DL associated with \<33% of 9 participants experiencing a DLT. The MTD was estimated to be palbociclib 100mg once daily on Days 1-21 plus nab-paclitaxel 125mg/m\^2 weekly for 3 weeks of a 28-day cycle based on data from the dose escalation cohorts. 6 None 12 20 20 20 View
MTD+DL3B The combined DL3B+MTD cohort was 7 first line participants from the DL3B cohort and all patients from the MTD cohort. 7 None 15 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v22.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Gastric haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Intestinal obstrucion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Bile duct obstruction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Escherichia infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Gastritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v22.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Neoplasm progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v22.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Device occlusion NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA v22.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v22.0 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Liver abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v22.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v22.0 View
Eye haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v22.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v22.0 View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v22.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Faeces discoloured NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Impaired gastric emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Mouth haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v22.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Catheter site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Early satiety NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
Bile duct obstruction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Biliary dilatation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Deficiency of bile secretion NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Hypertransaminasaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Ocular icterus NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v22.0 View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Escherichia infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Infected dermal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Nail infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Perinephric abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v22.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v22.0 View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v22.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v22.0 View
Activated partial thromboplastin time abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v22.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Iron deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v22.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Pain in jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v22.0 View
Malignant neoplasm progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v22.0 View
Tumor pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v22.0 View
Ageusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Dizziness postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Mental impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Neurotoxicity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Semnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Speech disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Taste disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v22.0 View
Confusion state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v22.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v22.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v22.0 View
Choluria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v22.0 View
Micturition disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v22.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Dermatitis acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Nail discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Nail toxicity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Onychomadesis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Pruritus generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v22.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v22.0 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v22.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v22.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v22.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v22.0 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v22.0 View