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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT00842712
Description:
The analysis was performed on safety population, defined as all participants who received any dose of the trial treatment (cilengitide, cetuximab, or chemotherapy), whereby participants were analyzed according to the actual treatment they received.
Frequency Threshold:
5
Time Frame:
Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date (26 Jun 2013)
Study:
NCT00842712
Study Brief:
Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m\^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m\^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks. | None | None | 0 | 3 | 3 | 3 | View |
| Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks. | None | None | 2 | 3 | 3 | 3 | View |
| Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks. | None | None | 1 | 3 | 3 | 3 | View |
| Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin | Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 intravenous infusion on Days 1 and 8 for 3 weeks. | None | None | 0 | 3 | 3 | 3 | View |
| Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles. | None | None | 42 | 85 | 84 | 85 | View |
| Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles. | None | None | 29 | 50 | 48 | 50 | View |
| Randomized Part: Cetuximab + Chemotherapy | Cetuximab 400 mg/m\^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m\^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles. | None | None | 45 | 80 | 78 | 80 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| TUMOUR EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| RENAL FAILURE ACUTE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| RENAL FAILURE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| ANAPHYLACTIC REACTION | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.0) | View |
| DRUG HYPERSENSITIVITY | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.0) | View |
| HAEMOGLOBIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| CONFUSIONAL STATE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| HYPOACUSIS | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| PERIORBITAL OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| CHOLECYSTITIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| HAEMATOCHEZIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| PULMONARY EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HAEMOPTYSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PULMONARY THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| ACUTE RESPIRATORY DISTRESS SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPNOEA EXERTIONAL | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PNEUMOTHORAX | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| RESPIRATORY DISTRESS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| DISEASE PROGRESSION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| IMPAIRED HEALING | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| MEDICAL DEVICE COMPLICATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| STAPHYLOCOCCAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| BRONCHOPNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| BRONCHOPULMONARY ASPERGILLOSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| CYSTITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| DEVICE RELATED INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| DIVERTICULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| GASTROINTESTINAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| LUNG INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| NAIL BED INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PNEUMONIA BACTERIAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| PROTEUS INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| STAPHYLOCOCCAL SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| FEBRILE NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| FEBRILE BONE MARROW APLASIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| PANCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ABDOMINAL PAIN UPPER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DIVERTICULAR PERFORATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DUODENAL ULCER HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| LARGE INTESTINE PERFORATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| PROCTITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| AORTIC THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| ARTERIAL DISORDER | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| ARTERIAL THROMBOSIS LIMB | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| AXILLARY VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPOVOLAEMIC SHOCK | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| JUGULAR VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| PERIPHERAL EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| SHOCK | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| SUBCLAVIAN VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| SUPERIOR VENA CAVA SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| VENA CAVA THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| CEREBROVASCULAR ACCIDENT | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| CONVULSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| CENTRAL NERVOUS SYSTEM LESION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| COMA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| SOMNOLENCE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| STATUS EPILEPTICUS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| HIP FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| LIMB INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| FAILURE TO ANASTOMOSE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| INCISIONAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| SPINAL COMPRESSION FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| SPLENIC RUPTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| ACUTE MYOCARDIAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ARRHYTHMIA SUPRAVENTRICULAR | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| PERICARDIAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| STRESS CARDIOMYOPATHY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| VENTRICULAR TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPERCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPOMAGNESAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| MALIGNANT PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| METASTASES TO MENINGES | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ACNE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| SKIN TOXICITY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| SKIN FISSURES | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| NAIL TOXICITY | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ABDOMINAL PAIN UPPER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| HAEMORRHOIDS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| NON-CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| XEROSIS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| LYMPHOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| THROMBOCYTOSIS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPOMAGNESAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPOCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| HYPERKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPNOEA EXERTIONAL | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| HAEMOPTYSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| DYSPHONIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| PRODUCTIVE COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| WEIGHT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| HAEMOGLOBIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| WHITE BLOOD CELL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| DYSGEUSIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| PARAESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| NEUROPATHY PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MUSCULOSKELETAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MUSCLE SPASMS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| MUSCULOSKELETAL CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| PARONYCHIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| FOLLICULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| CONJUNCTIVITIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| DYSURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| HAEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| TINNITUS | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| HIRSUTISM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ECCHYMOSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| HYPERHIDROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| INTERTRIGO | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| PETECHIAE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| PHOTOSENSITIVITY REACTION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| ABDOMINAL DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ABDOMINAL PAIN LOWER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| DYSPHAGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ERUCTATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| GASTRIC ULCER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| ORAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| OROPHARYNGEALPAIN | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| MIGRAINE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| ANOREXIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| IRON DEFICIENCY | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| IRON OVERLOAD | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| FEBRILE NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| ORTHOSTATIC HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| PERIPHERAL COLDNESS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| THROMBOPHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| CATHETER SITE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| NAIL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| RHINITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| TRACHEOBRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| VAGINAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| NEUTROPHIL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD CREATINE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| BLOOD SODIUM DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| C-REACTIVE PROTEIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| VISION BLURRED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| BLEPHARITIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| EYE IRRITATION | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| EYE PAIN | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| LEUKOCYTURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| POLLAKIURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| POLYURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| PALPITATIONS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| DYSPAREUNIA | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| ERECTILE DYSFUNCTION | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| TUMOUR PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |