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:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
NCT ID:
NCT00778258
Description:
None
Frequency Threshold:
5
Time Frame:
Enrollment through end of study (up to 3 years)
Study:
NCT00778258
Study Brief:
Study of Milk Allergy and Tolerance in Children
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Escalation - Reacted to Pizza | At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months. | None | None | 1 | 16 | 16 | 16 | View |
| Dose Escalation - Reacted to Rice Pudding | At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months. | None | None | 0 | 5 | 5 | 5 | View |
| Dose Escalation - Reacted to Non-baked Milk | At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months. | None | None | 0 | 20 | 20 | 20 | View |
| Maintenance - Reacted to Pizza | At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months. | None | None | 0 | 15 | 15 | 15 | View |
| Maintenance - Reacted to Rice Pudding | At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months. | None | None | 1 | 6 | 6 | 6 | View |
| Maintenance - Reacted to Non-baked Milk | At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months. | None | None | 0 | 23 | 23 | 23 | View |
| Non-Randomized - Tolerant to Baked and Non-baked Milk | At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets. | None | None | 0 | 10 | 4 | 10 | View |
| Not Randomized - Comparison | Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups | None | None | 0 | 34 | 20 | 34 | View |
| Non-Randomized - Reacted to Muffin | At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months | None | None | 0 | 41 | 40 | 41 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 11.1 | View |
| Growth hormone deficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 11.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Eosinophilic oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Rectal prolapse | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Allergy to animal | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.1 | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.1 | View |
| Milk allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 11.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| H1N1 influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Oral viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Lactose intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Bronchial hyperreactivity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Nasal oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |