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 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
NCT ID:
NCT01137604
Description:
All participants were followed for survival until death, except where a participant withdrew consent, or the Sponsor stopped the survival follow-up during the extension phase after completion of the primary study analysis. Since death was not a protocol defined reason for non-completion, the all cause mortality data below are not reflected in the Participant Flow section.
Frequency Threshold:
5
Time Frame:
For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)
Study:
NCT01137604
Study Brief:
A Study in Subjects With Recurrent Malignant Glioma
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 1 - Lenvatinib | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \[GBM\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles | 38 | None | 22 | 42 | 40 | 42 | View |
| Cohort 2 - Lenvatinib | Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles | 27 | None | 12 | 39 | 39 | 39 | View |
| Cohort 3 - Lenvatinib | Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles | 30 | None | 15 | 32 | 31 | 32 | View |
| Cohort 1 - Bevacizumab | Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \[GBM\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles | 36 | None | 10 | 38 | 38 | 38 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MeDRA version 16.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA version 16.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA version 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA version 16.0 | View |
| Hepatitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA version 16.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA version 16.0 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA version 16.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA version 16.0 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA version 16.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Hemianopia homonymous | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Pyramidal tract syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA version 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA version 16.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA version 16.0 | View |
| Rectal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA version 16.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA version 16.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA version 16.0 | View |
| Splinter haemorrhages | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA version 16.0 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MeDRA version 16.0 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MeDRA version 16.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MeDRA version 16.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Faecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Tongue ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA version 16.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA version 16.0 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA version 16.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA version 16.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA version 16.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA version 16.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA version 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA version 16.0 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Hemianopia homonymous | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Pyramidal tract syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA version 16.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Flat affect | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA version 16.0 | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA version 16.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA version 16.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA version 16.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA version 16.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Painful respiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA version 16.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA version 16.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA version 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA version 16.0 | View |