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 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT03926728
Description:
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
Frequency Threshold:
0
Time Frame:
Up to 238 days after first vaccination
Study:
NCT03926728
Study Brief:
Safety and Immunogenicity of a Chlamydia Vaccine CTH522
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140. | 0 | None | 0 | 2 | 2 | 2 | View |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. | 0 | None | 0 | 9 | 9 | 9 | View |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140. | 0 | None | 0 | 9 | 9 | 9 | View |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. | 0 | None | 0 | 9 | 9 | 9 | View |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. | 0 | None | 0 | 9 | 9 | 9 | View |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. | 0 | None | 0 | 9 | 9 | 9 | View |
| Cohort F1 IM Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140. | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Eyelid irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Swelling of eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Abdominal rigidity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site movement impairment | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Gallbladder polyp | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22.1 | View |
| Campylobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Corona virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Gonorrhoea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tinea pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Heat stroke | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Haemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Mean cell volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Muscle twitching | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pubic pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Ageusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Anosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Muscle contractions involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Attention deficit/hyperactivity disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Nasal pruritus | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Photosensitivity reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Pityriasis rosea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Deafness bilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Ear congestion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Erythema of eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |