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 @ 2:29 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT04074759
Description: A TEAE is an AE not present before the study drug or worsened during treatment and within 100 days after the last dose. An SAE is any untoward medical occurrence that is life-threatening, requires hospitalization or prolongs it, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.
Frequency Threshold: 5
Time Frame: Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination. Time frame for all-cause mortality was up to approximately 30 months.
Study: NCT04074759
Study Brief: FPT155 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
Phase 1a Monotherapy: FPT155 Dose A Participants with advanced solid tumours received FPT155 IV Q3W in escalating doses (A-L) until the RD was identified. 1 None 1 1 0 1 View
Phase 1a Monotherapy: FPT155 Dose B Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 0 None 0 1 1 1 View
Phase 1a Monotherapy: FPT155 Dose C Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 1 None 1 2 2 2 View
Phase 1a Monotherapy: FPT155 Dose D Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 1 None 0 1 1 1 View
Phase 1a Monotherapy: FPT155 Dose E Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 2 None 1 4 3 4 View
Phase 1a Monotherapy: FPT155 Dose F Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 0 None 1 3 2 3 View
Phase 1a Monotherapy: FPT155 Dose G Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 1 None 3 3 3 3 View
Phase 1a Monotherapy: FPT155 Dose H Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 0 None 0 3 3 3 View
Phase 1a Monotherapy: FPT155 Dose I Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 3 None 2 7 6 7 View
Phase 1a Monotherapy: FPT155 Dose J Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 2 None 3 10 10 10 View
Phase 1a Monotherapy: FPT155 Dose K Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 4 None 10 20 18 20 View
Phase 1a Monotherapy: FPT155 Dose L Participants with advanced solid tumours received FPT155 IV once Q3W in escalating doses (A-L) until the RD was identified. 1 None 2 6 5 6 View
Phase 1b Monotherapy: 1bM1 FPT155 Dose K Participants with advanced renal cell carcinoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). 0 None 1 1 1 1 View
Phase 1b Monotherapy: 1bM2 FPT155 Dose K Participants with advanced melanoma were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). 2 None 0 5 5 5 View
Phase 1b Monotherapy: 1bM3 FPT155 Dose K Participants with previously treated unresectable or metastatic non-small cell lung cancer and an absence of suitable standard treatment options were treated with FPT155 IV Q3W at the RD identified in Phase 1a monotherapy (Dose K). 1 None 2 3 3 3 View
Phase 1b Monotherapy: 1bM4 FPT155 Dose K Participants with previously treated solid tumors with a response to prior PD-1 or PDL-1 directed treatment as defined by an objective response (partial or complete response) as determined by the Investigator per RECIST v1.1,or a minimum of 3 months on prior PD-1 or PDL-1 directed therapy were treated with FPT155 at the RD identified in Phase 1a monotherapy (Dose K). 0 None 0 1 1 1 View
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg Participants with non-small cell lung cancer were treated with FTB155 Dose H administered IV Q3W in combination with 200 mg Pembrolizumab. 1 None 2 3 3 3 View
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg Participants with non-small cell lung cancer were treated with FTB155 Dose I administered IV Q3W in combination with 200 mg Pembrolizumab. 0 None 3 3 3 3 View
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg Participants with non-small cell lung cancer were treated with FTB155 Dose J administered IV Q3W in combination with 200 mg Pembrolizumab. 1 None 2 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia respiratory syncytial viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Central nervous system lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Giant cell arteritis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Infusion site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Lumbosacral radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Venous occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View