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 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
NCT ID:
NCT01232556
Description:
Adverse Events calculated using safety population. One subject in the rituximab+ inotuzumab ozogamicin arm received rituximab only, and was excluded from the safety population analysis. AE summaries below are inclusive of AEs from first dose date up to 56 days after last dose of study drug.
Frequency Threshold:
5
Time Frame:
Up to 22 weeks after the informed consent
Study:
NCT01232556
Study Brief:
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Inotuzumab Ozogamicin+Rituximab | Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles. | None | None | 61 | 164 | 155 | 164 | View |
| Rituximab+Gemcitabine or Rituximab+Bendamustine | Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator. | None | None | 63 | 167 | 158 | 167 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal wall haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Oedema due to hepatic disease | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Sudden death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v17.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v17.0 | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v17.0 | View |
| Atrial tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v17.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v17.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v17.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Cytomegalovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Cytomegalovirus viraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Infectious pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Oesophageal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pneumocystis jirovecii pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pneumonia fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Salmonella sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Staphylococcal skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Streptococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Spinal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Transfusion reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Urinary tract obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v17.0 | View |
| Hepatitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v17.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v17.0 | View |
| Venoocclusive liver disease | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v17.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Carotid artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| IIIrd nerve paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Paraplegia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| VIIth nerve paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Delirium febrile | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v17.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v17.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Febrile bone marrow aplasia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Splenic infarction | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | View |
| Myelodysplastic syndrome transformation | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v17.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v17.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v17.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v17.0 | View |