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 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
NCT ID:
NCT01089556
Description:
None
Frequency Threshold:
1
Time Frame:
None
Study:
NCT01089556
Study Brief:
A Study in Painful Diabetic Neuropathy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Duloxetine (SP III) | Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III). | None | None | 3 | 73 | 18 | 73 | View |
| Pregabalin (SP III) | Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III. | None | None | 2 | 97 | 37 | 97 | View |
| Duloxetine (SP II) | Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II). | None | None | 12 | 401 | 216 | 401 | View |
| Pregabalin (SP II) | Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II. | None | None | 13 | 403 | 225 | 403 | View |
| DLX + PGB (SP III) | Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III. | None | None | 3 | 75 | 21 | 75 | View |
| PGB + DLX (SP III) | Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III. | None | None | 5 | 94 | 39 | 94 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA (13.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Pilonidal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Brain contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Hepatitis c antibody positive | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Large intestine carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA (13.1) | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA (13.1) | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Myelitis transverse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA (13.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA (13.1) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA (13.1) | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA (13.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA (13.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA (13.1) | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MEDDRA (13.1) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MEDDRA (13.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MEDDRA (13.1) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MEDDRA (13.1) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA (13.1) | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA (13.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Chapped lips | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA (13.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Therapeutic response unexpected | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA (13.1) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Muscle rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Subcutaneous haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA (13.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Visual acuity tests abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Vitamin b12 decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA (13.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA (13.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Muscle contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA (13.1) | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Hypotonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Migraine with aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Psychomotor skills impaired | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Sedation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Sensory loss | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA (13.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Apathy | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Dissociation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Libido decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Loss of libido | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA (13.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA (13.1) | View |
| Urinary hesitation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA (13.1) | View |
| Urine flow decreased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA (13.1) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA (13.1) | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA (13.1) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA (13.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA (13.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA (13.1) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA (13.1) | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Venous insufficiency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA (13.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA (13.1) | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA (13.1) | View |