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 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
NCT ID:
NCT00963157
Description:
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Frequency Threshold:
5
Time Frame:
Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination.
Study:
NCT00963157
Study Brief:
Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 7.5 mcg H1N1 Vaccine Unadjuvanted | Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21. | None | None | 12 | 160 | 124 | 160 | View |
| 15 mcg H1N1 Vaccine + AS03 Adjuvant | Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21. | None | None | 8 | 157 | 146 | 157 | View |
| 15 mcg H1N1 Vaccine Unadjuvanted | Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21. | None | None | 8 | 153 | 130 | 153 | View |
| 3.75 mcg H1N1 Vaccine + AS03 Adjuvant | Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21. | None | None | 6 | 156 | 147 | 156 | View |
| 7.5 mcg H1N1 Vaccine + AS03 Adjuvant | Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21. | None | None | 7 | 163 | 157 | 163 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Endometrial cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Post procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Non-small cell lung cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Hysterectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.0) | View |
| Sick sinus syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Grand mal convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Gastric bypass | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.0) | View |
| Aqueductal stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pulmonary fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Spinal laminectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.0) | View |
| Chronic lymphocytic leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Respiratory fume inhalation disorder | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Pharyngeal oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Aortic valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Atrial septal defect repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Dementia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Implantable defibrillator insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.0) | View |
| Hepatic cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Haemophilus sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Cervical myelopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Bladder prolapse | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site swelling (functional grading) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Injection site swelling (measured) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Injection site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |