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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
NCT ID:
NCT02257567
Description:
All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Frequency Threshold:
5
Time Frame:
From Baseline up to study completion/discontinuation (up to approximately 84 months)
Study:
NCT02257567
Study Brief:
A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola. | 4 | None | 5 | 6 | 6 | 6 | View |
| Arm A (Phase II Randomization): Pola+BR in FL | Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola. | 16 | None | 25 | 38 | 38 | 38 | View |
| Arm C (Phase II Randomization): Pola+BR in DLBCL | Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola. | 26 | None | 24 | 39 | 36 | 39 | View |
| Arm D (Phase II Randomization): BR in DLBCL | Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6. | 30 | None | 27 | 39 | 37 | 39 | View |
| Arm E (Phase II Expansion): Pola+BG in FL | Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola. | 3 | None | 8 | 20 | 20 | 20 | View |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola. | 18 | None | 13 | 20 | 19 | 20 | View |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola. | 65 | None | 57 | 106 | 103 | 106 | View |
| Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola. | 2 | None | 2 | 6 | 6 | 6 | View |
| Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola. | 2 | None | 4 | 6 | 6 | 6 | View |
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola. | 2 | None | 4 | 6 | 6 | 6 | View |
| Arm B (Phase II Randomization): BR in FL | Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6. | 11 | None | 12 | 41 | 39 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| MYOCARDIAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DUODENAL ULCER HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ENTERITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| OBSTRUCTION GASTRIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| CYTOMEGALOVIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ENTEROCOLITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ESCHERICHIA BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| GASTROINTESTINAL BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| GIARDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| HEPATITIS E | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| HERPES VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| HUMAN ANAPLASMOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| INFECTED LYMPHOCELE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| LARGE INTESTINE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| MENINGOENCEPHALITIS HERPETIC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| NEUTROPENIC SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| OESOPHAGEAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ORAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PLEURAL INFECTION BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA CYTOMEGALOVIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA FUNGAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA PNEUMOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| POST PROCEDURAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| RESPIRATORY TRACT INFECTION VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| RHINOVIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| HEAD INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| POST PROCEDURAL FEVER | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| MORAXELLA TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| TUMOUR LYSIS SYNDROME | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| ADENOCARCINOMA GASTRIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| ADENOCARCINOMA OF COLON | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| ENDOMETRIAL ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| ENDOMETRIAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| INTESTINAL ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| LYMPHOCYTIC LEUKAEMIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| MYELODYSPLASTIC SYNDROME | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| CAROTID ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| HAEMORRHAGE INTRACRANIAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| LEUKOENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| VOCAL CORD PARALYSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| ACUTE PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| BRONCHOPNEUMOPATHY | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| HYPERVENTILATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| DRUG ERUPTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| RASH ERYTHEMATOUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| DISTRIBUTIVE SHOCK | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| THROMBOPHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| ATRIAL THROMBOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| ENTEROCOLITIS HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| VASCULAR ACCESS SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| EPIGLOTTIC CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| PANCREATIC CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| RENAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| CYTOMEGALOVIRUS CHORIORETINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CYTOMEGALOVIRUS COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| HEPATIC CIRRHOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 24.1 | View |
| HYPERTRANSAMINASAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 24.1 | View |
| ISCHAEMIC HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 24.1 | View |
| ABDOMINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ABDOMINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ARTHRITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CEREBRAL TOXOPLASMOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CLOSTRIDIAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CLOSTRIDIUM DIFFICILE COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| CYTOMEGALOVIRUS ENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| CEREBRAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| SINUS HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| PHLEBITIS SUPERFICIAL | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| IMMUNE THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| WOUND | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| HYPOACUSIS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 24.1 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| APHTHOUS ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ODYNOPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| HYPOGAMMAGLOBULINAEMIA | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 24.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| HERPES VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| C-REACTIVE PROTEIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOALBUMINAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| PERIPHERAL MOTOR NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| POST HERPETIC NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| THROAT IRRITATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| UPPER-AIRWAY COUGH SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| NIGHT SWEATS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| COAGULOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| HAEMOLYSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| HAEMOLYTIC ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 24.1 | View |
| BUNDLE BRANCH BLOCK RIGHT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| VENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 24.1 | View |
| EYE DISCHARGE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 24.1 | View |
| EYE PRURITUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 24.1 | View |
| GLAUCOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 24.1 | View |
| OCULAR HYPERAEMIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 24.1 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 24.1 | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| ANAL SPASM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DEFAECATION URGENCY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| GINGIVAL BLEEDING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| GINGIVAL DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| GINGIVAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| HAEMATEMESIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| HAEMATOCHEZIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| LIP DRY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| NONINFECTIVE GINGIVITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| RECTAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 24.1 | View |
| CATHETER SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| CATHETER SITE PRURITUS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| EARLY SATIETY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 24.1 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 24.1 | View |
| CANDIDA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CLOSTRIDIUM DIFFICILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CYTOMEGALOVIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| CYTOMEGALOVIRUS VIRAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| EAR INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ESCHERICHIA URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| FOLLICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| RASH PUSTULAR | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ARTHROPOD BITE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| COMMINUTED FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 24.1 | View |
| AMYLASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| BLOOD CALCIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| BLOOD MAGNESIUM DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| BLOOD PHOSPHORUS DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| LIVER FUNCTION TEST ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| NEUTROPHIL COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| TROPONIN I INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| TROPONIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 24.1 | View |
| HYPERPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| LACTIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| MALNUTRITION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| VITAMIN D DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 24.1 | View |
| CERVICAL SPINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| GROIN PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| INTERVERTEBRAL DISC DEGENERATION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MUSCLE TIGHTNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| MUSCULOSKELETAL STIFFNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | View |
| HODGKIN'S DISEASE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| MYELODYSPLASTIC SYNDROME | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| TUMOUR PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |
| AMNESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| DYSKINESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| PERONEAL NERVE PALSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| RESTLESS LEGS SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| TASTE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 24.1 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 24.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| ANURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 24.1 | View |
| ERECTILE DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 24.1 | View |
| TESTICULAR PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 24.1 | View |
| TESTICULAR SWELLING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 24.1 | View |
| VAGINAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 24.1 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 24.1 | View |
| BRONCHOSPASM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| HICCUPS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| NASAL DISCHARGE DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| ORGANISING PNEUMONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| SINUS CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| SINUS PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| TACHYPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| RASH MACULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| SKIN DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| PALLOR | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 24.1 | View |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 24.1 | View |
| VASCULAR ACCESS SITE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 24.1 | View |
| ENDOMETRIAL ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.1 | View |