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 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
NCT ID:
NCT00527735
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00527735
Study Brief:
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC | During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure. | None | None | 49 | 71 | 63 | 71 | View |
| Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC | During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure. | None | None | 36 | 67 | 63 | 67 | View |
| Placebo + Paclitaxel/Carboplatin NSCLC | During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose. | None | None | 33 | 65 | 59 | 65 | View |
| Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC | During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure. | None | None | 25 | 42 | 36 | 42 | View |
| Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC | During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure. | None | None | 21 | 42 | 39 | 42 | View |
| Placebo + Paclitaxel/Carboplatin SCLC | During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose. | None | None | 20 | 44 | 41 | 44 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SIALOADENITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| TUMOUR PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| ARTERIAL THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| AUTOIMMUNE HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| GASTROENTERITIS SHIGELLA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| HYPOPITUITARISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 13.0 | View |
| MALIGNANT PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| METABOLIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| METASTATIC NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| ERYTHEMA MULTIFORME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| LEUKOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| LUNG NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| MALIGNANT NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| BRONCHITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| CACHEXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| HEPATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| HYPOPHYSITIS | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 13.0 | View |
| MULTI-ORGAN FAILURE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| PERICARDIAL EFFUSION MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| RASH MACULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| TACHYARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| THROMBOPHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| ATAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| BRONCHOSPASM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| FEBRILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| GASTROINTESTINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| ILEAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| LUNG CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| OBSTRUCTIVE AIRWAYS DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| OPTIC ISCHAEMIC NEUROPATHY | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 13.0 | View |
| PSEUDOMONAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 13.0 | View |
| TOXIC EPIDERMAL NECROLYSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| CERVICAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| CLOSTRIDIUM DIFFICILE COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| DERMATITIS EXFOLIATIVE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 13.0 | View |
| MACULAR CYST | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 13.0 | View |
| MALNUTRITION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| NON-SMALL CELL LUNG CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| SALIVARY GLAND CALCULUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 13.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 13.0 | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| DUODENAL ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ENTERITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| GASTROINTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| GRAND MAL CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| MEDIASTINAL DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| MENINGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| METASTASES TO CENTRAL NERVOUS SYSTEM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| OESOPHAGEAL DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| PATHOLOGICAL FRACTURE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| PERIPHERAL SENSORIMOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| PULMONARY HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| ABDOMINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| BASAL GANGLIA HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| BILIARY COLIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| EROSIVE OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| HEPATOTOXICITY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| LOCALISED OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| LUNG NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | View |
| MONOPLEGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| PERIPHERAL MOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| TRACHEO-OESOPHAGEAL FISTULA | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 13.0 | View |
| ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| BILE DUCT STENOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| DROWNING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| GASTRITIS EROSIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 13.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| ICHTHYOSIS | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 13.0 | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| OCCIPITAL NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| PLEURAL INFECTION BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| VENTRICULAR FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 13.0 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| PERIPHERAL MOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 13.0 | View |