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 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
NCT ID:
NCT00625404
Description:
These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00625404
Study Brief:
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Truvada Arm | Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg). | None | None | 33 | 1025 | 761 | 1025 | View |
| Placebo Arm | Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. | None | None | 23 | 1033 | 749 | 1033 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| exomphalos | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (10.0) | View |
| typhoid fever | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Bartholin's abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| pelvic inflammatory disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| abdominal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| joint contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| joint dislocation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| muscular weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| abortion | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| ectopic pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| foetal distress syndrome | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| premature rupture of the membranes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| intentional overdose | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| removal of foreign body | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.0) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Exomphalos | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (10.0) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Otorrhoea | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Abnormal vision | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Typhoid fever | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dysentery | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Hyperphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Rectal prolapse | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Thirst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Pruritus allergic | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Allergic cough | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Allergic sinusitis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Idiopathic urticaria | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vaginitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Chlamydial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Tinea infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Pelvic inflammatory disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Trichomoniasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Cervicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Gonorrhoea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vulvovaginitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Helminthic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Amoebiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Bartholin's abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Extrapulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Human bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Incision site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Periorbital haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Abdominal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Anthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Contusion of knee | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Face injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Mouth injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Blood phosphorus increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Eosinophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Glucose urine | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Heart rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Hormonal level abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Renal function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Joint contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Muscle mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Osteitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Neuritis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Abortion | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Ectopic pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Foetal distress syndrome | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Vomiting in pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Abortion threatened | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Premature rupture of the membranes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Somatoform disorder pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | View |
| Intentional overdose | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Dysfunctional uterine bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Genital ulceration | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Premenstrual syndrome | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Breast discomfort | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Coital bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Dyspareunia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Galacthorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Genital erosion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Menometrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Vaginal ulceration | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hyperventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pulmonary congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Chloasma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Scar pain | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Skin hypopigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Physical assault | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (10.0) | View |
| Removal of foreign body | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Venous insufficiency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |