NOHARM AE definitions
| . | Definition . |
|---|---|
| Clinical AE terminology | |
| Vaso-occlusive pain crisis/dactylitis | Vaso-occlusive pain crisis: acute pain and tenderness in an area of the body, with or without swelling, with no other diagnostic explanation. |
| Dactylitis: vaso-occlusive crisis (acute pain, tenderness, and swelling) localized to hands or feet. | |
| Pneumonia/acute chest syndrome | Pneumonia: history of fever or measured axillary temperature ≥37.5°C, with tachypnea and cough. |
| Acute chest syndrome: signs of pneumonia plus chest pain and/or tenderness. | |
| Clinical sepsis | Measured fever and ill appearance, requiring IV antibiotics. |
| Acute splenic sequestration | Increase in splenic size from last physical examination, accompanied by a decrease in hemoglobin of ≥2 g/dL. |
| Upper respiratory infection | Child with general well appearance with rhinorrhea, nasal congestion, or cough. |
| Gastrointestinal related | Diarrhea, vomiting, constipated, intestinal obstruction. |
| Malaria | Measured fever (axillary temperature ≥37.5°C) or fever by history and Plasmodium species infection on blood smear. |
| Other infection | Other infections, diagnosed clinically. |
| Other (eg, injury) | Other diseases not included above diagnosed during visits for illness. |
| Laboratory AEs* | |
| Anemia | Hemoglobin <6 g/dL |
| Reticulocytopenia | ARC <80 × 109/L and hemoglobin <7 g/dL |
| Neutropenia | Absolute neutrophil count (ANC) <1.0 × 109/L |
| Thrombocytopenia | Platelet count <80 × 109/L |
| Elevated AST/ALT | AST >150 IU/L, ALT >150 IU/L |
| Elevated bilirubin | Total bilirubin >5 mg/dL |
| . | Definition . |
|---|---|
| Clinical AE terminology | |
| Vaso-occlusive pain crisis/dactylitis | Vaso-occlusive pain crisis: acute pain and tenderness in an area of the body, with or without swelling, with no other diagnostic explanation. |
| Dactylitis: vaso-occlusive crisis (acute pain, tenderness, and swelling) localized to hands or feet. | |
| Pneumonia/acute chest syndrome | Pneumonia: history of fever or measured axillary temperature ≥37.5°C, with tachypnea and cough. |
| Acute chest syndrome: signs of pneumonia plus chest pain and/or tenderness. | |
| Clinical sepsis | Measured fever and ill appearance, requiring IV antibiotics. |
| Acute splenic sequestration | Increase in splenic size from last physical examination, accompanied by a decrease in hemoglobin of ≥2 g/dL. |
| Upper respiratory infection | Child with general well appearance with rhinorrhea, nasal congestion, or cough. |
| Gastrointestinal related | Diarrhea, vomiting, constipated, intestinal obstruction. |
| Malaria | Measured fever (axillary temperature ≥37.5°C) or fever by history and Plasmodium species infection on blood smear. |
| Other infection | Other infections, diagnosed clinically. |
| Other (eg, injury) | Other diseases not included above diagnosed during visits for illness. |
| Laboratory AEs* | |
| Anemia | Hemoglobin <6 g/dL |
| Reticulocytopenia | ARC <80 × 109/L and hemoglobin <7 g/dL |
| Neutropenia | Absolute neutrophil count (ANC) <1.0 × 109/L |
| Thrombocytopenia | Platelet count <80 × 109/L |
| Elevated AST/ALT | AST >150 IU/L, ALT >150 IU/L |
| Elevated bilirubin | Total bilirubin >5 mg/dL |
The diagnosis of sickle-related clinical events followed published definitions,24 with modifications such as pneumonia and clinical sepsis.
ALT, alanine transferase; AST, aspartate transferase.
Laboratory AE definitions represent the values necessary for a grade 2 event.