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 @ 12:19 PM
Ignite Modification Date:
2025-12-25 @ 12:02 PM
NCT ID:
NCT03483961
Description:
One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Frequency Threshold:
5
Time Frame:
Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported.
Study:
NCT03483961
Study Brief:
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 0 | None | 0 | 53 | 26 | 53 | View |
| Group 2: 6 mcg/Adjuvant (Day 1 & 29) | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 1 | 52 | 35 | 52 | View |
| Group 3: 10 mcg/Adjuvant (Day 1 & 29) | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 2 | 50 | 36 | 50 | View |
| Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 1 | 51 | 34 | 51 | View |
| Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 0 | 53 | 29 | 53 | View |
| Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 2 | 51 | 30 | 51 | View |
| Group 8: 40 mcg/Adjuvant (Day 29) | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 3 | 52 | 34 | 52 | View |
| Group 9: 20 mcg/Adjuvant (Day 1 & 29) | 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | 0 | None | 0 | 20 | 12 | 20 | View |
| Group 10: 40 mcg/Adjuvant (Day 1) | 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | 0 | None | 0 | 10 | 4 | 10 | View |
| Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 0 | None | 0 | 53 | 28 | 53 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Biliary dyskinesia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Induced abortion haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Laryngeal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Hyperemesis gravidarum | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | View |
| Premature separation of placenta | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | View |
| Threatened labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Hangover | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Nausea, solicited | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Injection site pain, solicited | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Fatigue, solicited | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Malaise, solicited | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Chills, solicited | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Myalgia, solicited | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Arthralgia, solicited | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Headache, solicited | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Pyrexia, solicited | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |