Adverse Events Module

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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: 2025-12-25 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:04 PM
NCT ID: NCT02859558
Description: All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used. Fiebig VI/HIV Negative could not enroll to Step 2.
Frequency Threshold: 0
Time Frame: Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.
Study: NCT02859558
Study Brief: Early ART to Limit Infection and Establishment of Reservoir
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Step 1 Arm 1: Fiebig I/II Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 0 None 5 49 48 49 View
Step 1 Arm 2: Fiebig III/IV Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 0 None 7 79 67 79 View
Step 1 Arm 3: Fiebig V Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 0 None 4 60 50 60 View
Step 1 Fiebig VI Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 0 None 0 4 4 4 View
Step1 HIV Negative Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment. 0 None 0 3 2 3 View
Step 2 Arm 1: Fiebig I/II Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody) that enrolled to Step 2. elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 1 None 6 26 18 26 View
Step 2 Arm 2: Fiebig III/IV Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2) that enrolled to Step 2. elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 0 None 4 42 30 42 View
Step 2 Arm 3: Fiebig V Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band) that enrolled to Step 2. elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen. 0 None 3 23 15 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Large intestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Cervical cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 28.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 28.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 28.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 28.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Escherichia pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Fascial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Lymphadenitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Monkeypox SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Peritonsillar abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Secondary syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Hepatitis B surface antigen positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 28.0 View
Adjustment disorder with depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Substance-induced psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 28.0 View
Vascular skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urethritis ureaplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Vulvovaginitis gonococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 28.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 28.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 28.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 28.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Chlamydia test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Neisseria test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Syphilis test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Trichomonal test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Tuberculin test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Abnormal loss of weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Penile ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 28.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 28.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 28.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 28.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 28.0 View
Tachycardia paroxysmal SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 28.0 View
Thalassaemia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 28.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 28.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 28.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Anogenital dysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 28.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 28.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 28.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 28.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Acute hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Anal chlamydia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Anal gonococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Bacterial diarrhoea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Balanitis candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Chlamydial cervicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Epididymitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Genital herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Genitourinary chlamydia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Genitourinary tract gonococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Helicobacter gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Herpes simplex anorectal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Latent syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Monkeypox SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Neurosyphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Oropharyngeal gonococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Pharyngeal chlamydia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Primary syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Proctitis chlamydial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Proctitis gonococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Scabies SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Secondary syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Shigella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Sinusitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Syphilis genital SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Tinea versicolour SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Tonsillitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Trichomoniasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Tubo-ovarian abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Urethritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Urethritis chlamydial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Urethritis gonococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 28.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 28.0 View
Vitamin B complex deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 28.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Facet joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Sacral pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 28.0 View
Anal papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 28.0 View
Anogenital warts SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 28.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 28.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 28.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 28.0 View
Adjustment disorder with mixed anxiety and depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Agitated depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Mixed anxiety and depressive disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 28.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 28.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 28.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 28.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 28.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 28.0 View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 28.0 View
Penile discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 28.0 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 28.0 View
Testicular swelling SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 28.0 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 28.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 28.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 28.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 28.0 View
Dyshidrotic eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 28.0 View
Essential hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 28.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 28.0 View