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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT00791700
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold:
2
Time Frame:
Baseline up to 5 years
Study:
NCT00791700
Study Brief:
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| >=2 - <6 Years of Age, MVC Liquid Formulation | In Cohort 1, Participants aged \>= 2 to \< 6 years, received MVC liquid formulation (20 mg/mL). | 0 | None | 5 | 16 | 12 | 16 | View |
| >=6 - <12 Years of Age, MVC Tablet Formulation | In Cohort 2, Participants aged \>=6 to \<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | 0 | None | 5 | 31 | 25 | 31 | View |
| >=6 - <12 Years of Age, MVC Liquid Formulation | In Cohort 3, Participants aged \>=6 to \<12 years, received MVC liquid formulation (20 mg/mL). | 0 | None | 3 | 13 | 10 | 13 | View |
| >=12 - <18 Years of Age, MVC Tablet Formulation | In Cohort 4, Participants aged \>=12 to \<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg). | 1 | None | 10 | 43 | 34 | 43 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v18.0) | View |
| Gastric fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Drug-induced liver injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v18.0) | View |
| Abscess oral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| H1N1 influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pelvic inflammatory disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Osteopenia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Tendon disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Prurigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Otorrhoea | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (v18.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v18.0) | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v18.0) | View |
| Lymphadenitis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v18.0) | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v18.0) | View |
| Cardiac disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (v18.0) | View |
| Deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (v18.0) | View |
| Conjunctival pallor | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v18.0) | View |
| Conjunctivitis allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v18.0) | View |
| Hypermetropia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v18.0) | View |
| Refraction disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (v18.0) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Anal pruritus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Gingival swelling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Odynophagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Salivary gland mucocoele | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Tongue disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (v18.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v18.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v18.0) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v18.0) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v18.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (v18.0) | View |
| Hepatotoxicity | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v18.0) | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (v18.0) | View |
| Allergy to arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (v18.0) | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Acarodermatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Bacterial vaginosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Bullous impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Fungal skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Herpes virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Latent tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Lice infestation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Otitis media chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Parotitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Oropharyngeal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Sinobronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tinea capitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tinea faciei | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tinea infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tracheitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Vulvovaginitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Accidental exposure to product | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Arthropod sting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Underdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Blood HIV RNA increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Blood iron decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Blood phosphorus decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Hepatic enzyme abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Viral load increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Insulin resistance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (v18.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Bone swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Myofascial pain syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Skin papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v18.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Generalised tonic-clonic seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Attention deficit/hyperactivity disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Hallucination | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Nightmare | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Panic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Amenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v18.0) | View |
| Breast enlargement | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v18.0) | View |
| Breast mass | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v18.0) | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v18.0) | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (v18.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Catarrh | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Pharyngeal disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Rhonchi | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Acanthosis nigricans | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Dermatitis diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Papule | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Prurigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Rash pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Urticaria papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (v18.0) | View |
| Cerumen impaction | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (v18.0) | View |
| Ear haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (v18.0) | View |
| Bronchial hyperreactivity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Allergic cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (v18.0) | View |
| Conjunctivitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Mastoiditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Viral rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Traumatic ulcer | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Traumatic haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (v18.0) | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Flat affect | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (v18.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (v18.0) | View |
| Angular cheilitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (v18.0) | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (v18.0) | View |
| Intellectual disability | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (v18.0) | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (v18.0) | View |
| Lipodystrophy acquired | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Neurodermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (v18.0) | View |
| Tooth extraction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (v18.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (v18.0) | View |