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 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
NCT ID:
NCT01271803
Description:
Safety data was not reported per dose/regimen cohort. Due to final analysis data for adverse events were reported collectively for both the reporting groups- Vemurafenib PD and BRAFi-naïve participants along with Cobimetinib Monotherapy. Data is presented based on the final CSR. As of 2017 per-cohort data were not collected.
Frequency Threshold:
5
Time Frame:
Up to 82 months
Study:
NCT01271803
Study Brief:
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vemurafenib PD Participants | All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. | None | None | 21 | 66 | 64 | 66 | View |
| Cobimetinib Monotherapy (100 mg or 60 mg) | Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met. | None | None | 0 | 2 | 2 | 2 | View |
| BRAFi-naïve Participants | All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. | None | None | 36 | 63 | 63 | 63 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Congestive cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.0 | View |
| Iridocyclitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Biloma | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Ophthalmic herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Pneumonia chlamydial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Keratoacanthoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Tonsil cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Vogt-koyanagi-harada syndrome | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Face Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Haemtemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Hypersenstivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Streptococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Adrenal neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Glomerulonephritis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Chorioretinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Bowen's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Photosensitivity reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Salpingo-Oophorectomy unilateral | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Photosensitivity reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Vitiligo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Keratosis pilaris | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Erythema nodosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Panniculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rosacea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Gamma-glutamyl transferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Seborrhoeic keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood alkaline phophatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Melanocytic naevus | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |