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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT00711802
Description:
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
Frequency Threshold:
1.0
Time Frame:
Baseline through 14 days after last dose of study drug
Study:
NCT00711802
Study Brief:
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Age Group 2: Daptomycin | Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years | None | None | 1 | 73 | 7 | 73 | View |
| Age Group 3: Daptomycin | Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years | None | None | 2 | 81 | 27 | 81 | View |
| Age Group 1: Daptomycin | Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years | None | None | 3 | 72 | 15 | 72 | View |
| Age Group 1: Standard of Care (SOC) | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years | None | None | 1 | 38 | 9 | 38 | View |
| Age Group 2: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years | None | None | 1 | 38 | 2 | 38 | View |
| Age Group 3: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years | None | None | 1 | 42 | 10 | 42 | View |
| Age Group 4: Daptomycin | Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to \<2 years | None | None | 0 | 30 | 11 | 30 | View |
| Age Group 4: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to \<2 years | None | None | 0 | 15 | 11 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest pain | None | General disorders | MedDRA (11.0) | View |
| Pyrexia | None | General disorders | MedDRA (11.0) | View |
| Abscess | None | Infections and infestations | MedDRA (11.0) | View |
| Bacteraemia | None | Infections and infestations | MedDRA (11.0) | View |
| Osteomyelitis | None | Infections and infestations | MedDRA (11.0) | View |
| Subcutaneous abscess | None | Infections and infestations | MedDRA (11.0) | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA (11.0) | View |
| Myopathy | None | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Status asthmaticus | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Wound drainage | None | Surgical and medical procedures | MedDRA (11.0) | View |
| Toxic shock syndrome | None | Infections and infestations | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cheilitis | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Infusion site extravasation | None | General disorders | MedDRA (11.0) | View |
| Infusion site pain | None | General disorders | MedDRA (11.0) | View |
| Pyrexia | None | General disorders | MedDRA (11.0) | View |
| Abscess neck | None | Infections and infestations | MedDRA (11.0) | View |
| Candida nappy rash | None | Infections and infestations | MedDRA (11.0) | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA (11.0) | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA (11.0) | View |
| Cellulitis | None | Infections and infestations | MedDRA (11.0) | View |
| Fungal infection | None | Infections and infestations | MedDRA (11.0) | View |
| Genital candidiasis | None | Infections and infestations | MedDRA (11.0) | View |
| Hand-foot-and-mouth disease | None | Infections and infestations | MedDRA (11.0) | View |
| Rhinitis | None | Infections and infestations | MedDRA (11.0) | View |
| Blood phosphorus increased | None | Investigations | MedDRA (11.0) | View |
| Lymphocyte percentage increase | None | Investigations | MedDRA (11.0) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (11.0) | View |
| Platelet count increased | None | Investigations | MedDRA (11.0) | View |
| Red blood cells urine | None | Investigations | MedDRA (11.0) | View |
| Hyperphosphataemia | None | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Headache | None | Nervous system disorders | MedDRA (11.0) | View |
| Pharyngeal lesion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Dermatitis diaper | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Rash papular | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |