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 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
NCT ID:
NCT01511250
Description:
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold:
5
Time Frame:
Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118).
Study:
NCT01511250
Study Brief:
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part I: Placebo 21 to 45 Years | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. | None | None | 0 | 14 | 7 | 14 | View |
| Part I: TDV 21 to 45 Years | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\*10\^4 plaque forming units (PFU), 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU. | None | None | 4 | 24 | 11 | 24 | View |
| Part I: TDV 12 to 20 Years | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\*10\^4 PFU, 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU. | None | None | 1 | 22 | 13 | 22 | View |
| Part I: Placebo 12 to 20 Years | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. | None | None | 0 | 14 | 8 | 14 | View |
| Part I: TDV 6 to 11 Years | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\*10\^4 PFU, 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU. | None | None | 4 | 21 | 9 | 21 | View |
| Part I: Placebo 6 to 11 Years | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. | None | None | 1 | 17 | 11 | 17 | View |
| Part I: TDV 1.5 to 5 Years | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\*10\^4 PFU, 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU. | None | None | 1 | 23 | 14 | 23 | View |
| Part I: Placebo 1.5 to 5 Years | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. | None | None | 2 | 13 | 12 | 13 | View |
| Part II: TDV 1.5 to 11 Years | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2\*10\^4 PFU, 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU respectively, total virus per dose: 4.7\*10\^5 PFU. | None | None | 14 | 159 | 87 | 159 | View |
| Part II: Placebo 1.5 to 11 Years | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. | None | None | 2 | 53 | 30 | 53 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.0) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.0) | View |
| Incision site haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Incision site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Brain contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Child maltreatment syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Skull fractured base | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (14.0) | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Gastritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Gastroenteritis rotavirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Hand-foot-and-mouth disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Viral rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.0) | View |
| Endometriosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.0) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Urticaria papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |