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 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
NCT ID:
NCT02349633
Description:
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Frequency Threshold:
5
Time Frame:
Baseline up to 28 days after last dose of study drug (up to a maximum of 199 weeks).
Study:
NCT02349633
Study Brief:
Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)
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 1 Dose-escalation: PF-06747775 25 mg QD | Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks). | 0 | None | 2 | 4 | 4 | 4 | View |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks). | 1 | None | 1 | 3 | 3 | 3 | View |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks). | 0 | None | 3 | 4 | 4 | 4 | View |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks). | 0 | None | 3 | 4 | 4 | 4 | View |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks). | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks). | 1 | None | 3 | 4 | 4 | 4 | View |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks). | 1 | None | 2 | 4 | 4 | 4 | View |
| PF-06747775 200 mg QD Group | Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1. | 0 | None | 3 | 29 | 29 | 29 | View |
| Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD | Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11. | 0 | None | 0 | 5 | 5 | 5 | View |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks). | 0 | None | 1 | 5 | 5 | 5 | View |
| Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin | Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination. | 0 | None | 0 | 0 | 0 | 0 | View |
| Phase 2 Cohort 2B: PF-06747775 + Palbociclib | Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination. | 0 | None | 0 | 0 | 0 | 0 | View |
| Phase 2 Cohort 2B: PF-06747775 Single Agent | Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination. | 0 | None | 0 | 0 | 0 | 0 | View |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Intracardiac thrombus | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Joint abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Ejection fraction decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Haemarthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Tumour pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Brain oedema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Sputum discoloured | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Hair texture abnormal | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Ingrowing nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Intertrigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Onychomadesis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Vitreous haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Bundle branch block right | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Congestive cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Hypoacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v23.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Conjunctival oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Corneal erosion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Erythema of eyelid | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Eyelid rash | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Eyelids pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Growth of eyelashes | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Macular degeneration | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Pterygium | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Trichomegaly | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Anal inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Oesophageal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Anal fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Candida infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Helicobacter gastritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Staphylococcal skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Tinea cruris | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Fractured sacrum | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood albumin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood calcium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood sodium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Creatinine renal clearance decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Oxygen saturation decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypermagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyperphosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypophagia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Joint range of motion decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Muscle tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Osteopenia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Tumour pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Aphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Balance disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Facial paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Azotaemia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Chronic kidney disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Prostatic obstruction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Vulvovaginal pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Vulvovaginal rash | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Nasal dryness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Nasal inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Paranasal sinus discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pleuritic pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Rash pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Skin fissures | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |