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 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
NCT ID:
NCT04649151
Description:
All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug.
Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.
Frequency Threshold:
5
Time Frame:
Day 1 up to Day 751
Study:
NCT04649151
Study Brief:
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
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 1C-1: mRNA-1273 50 µg BD | Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1. | 0 | None | 9 | 1408 | 429 | 1408 | View |
| Part 1C-2: mRNA-1273 50 μg BD | Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1. | 0 | None | 3 | 155 | 28 | 155 | View |
| Part 2: mRNA-1273 50 μg | Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29). | 0 | None | 0 | 52 | 12 | 52 | View |
| Part 2: mRNA-1273 50 ug BD | Participants received open-label mRNA-1273 50 µg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2. | 0 | None | 0 | 19 | 7 | 19 | View |
| Part 3: mRNA1273.222 50 µg 1 Dose | Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). | 0 | None | 12 | 388 | 77 | 388 | View |
| Part 3: mRNA-1273.222 50 ug Second Dose | Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181). | 1 | None | 4 | 335 | 51 | 335 | View |
| Part 1B: mRNA-1273 100 µg | Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273. | 0 | None | 2 | 96 | 22 | 96 | View |
| Part 1A: mRNA-1273 100 μg | Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29). | 0 | None | 21 | 2486 | 943 | 2486 | View |
| Part 1A: Placebo | Participants received at least 1 of 2 doses of placebo by IM injection (Day 1 and Day 29). | 0 | None | 4 | 1240 | 155 | 1240 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pectus excavatum | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 23.0 | View |
| Syringomyelia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 23.0 | View |
| Arnold-Chiari malformation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 23.0 | View |
| Normochromic normocytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 | View |
| Hyperbilirubinaemia neonatal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.0 | View |
| Amoebic dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Murine typhus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Gun shot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Post procedural fever | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Splenic injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Vulvovaginal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Abortion | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | View |
| Status migrainosus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Idiopathic generalised epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | View |
| Depression suicidal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Emotional distress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Nephrotic syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Obstructive nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Vaginal haematoma | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Hypercoagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Injection site lymphadenopathy | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Parainfluenzae virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Asymptomatic COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Mechanical urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Attention deficit hyperactivity disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Parapsoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |