Table 6 Classification of adverse events
Seriousness | A serious adverse event includes any untoward medical occurrence that at any dose: • Results in death, • Is life-threatening, • Requires inpatient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity, or • Is a congenital anomaly/birth defect Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the definition above may also be considered serious | ||
Severity | Grade 1 | Mild | Symptoms causing no or minimal interference with usual social and functional activities |
Grade 2 | Moderate | Symptoms causing greater than minimal interference with usual social and functional activities | |
Grade 3 | Severe | Symptoms causing inability to perform usual social and functional activities | |
Grade 4 | Potentially life- threatening | Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability | |
Grade 5 | Death | Â | |
Relationship to study products | Definitely related | The adverse event and administration of the study agent are related in time, and a direct association can be demonstrated | |
Probably related | The adverse event and administration of the study agent are reasonably associated in time, and the adverse event is more likely explained by the study agent than other causes | ||
Possibly related | The adverse event and administration of the study agent are reasonably related in time, and the adverse event can be explained equally well by causes other than the study agent | ||
Probably not related | A potential relationship between the study agent and the adverse event could exist (i.e. the possibility cannot be excluded), but the adverse event is most likely explained by causes other than the study agent | ||
Not related | The adverse event is clearly explained by another cause not related to the study agent | ||
Pending | Pending may be used as a temporary relationship assessment only for death and only if data necessary to determine relationship to the study agent are being collected. The site is required to submit a final assessment within three business days after reporting the death. If no final assessment is made within three business days after the date of submission, the event will be assessed as possibly related to the study agent. Any additional information received at a later time, including an autopsy report, should be submitted as a Follow-up Report | ||
Expectedness | Expected | Expected refers to the perspective of events previously observed, not on the basis of what might be anticipated from the pharmacological properties of the study agent | |
Study drug | Expected adverse events | ||
Trimethoprim-sulfamethoxazole | Rash, urticaria, loss of appetite, nausea, vomiting, agranulocytosis, aplastic anemia, disease of the hematopoietic system, fulminant hepatic necrosis, severe allergic reaction, Stevens-Johnson syndrome, and toxic epidermal necrolysis | ||
Chloroquine | Headache, malaise, dizziness, blurred vision, difficulty focusing, muscle weakness, electrocardiogram changes, gastrointestinal upset, mouth ulcers, diarrhea, vomiting, nonurticarial pruritis, leukopenia, methemoglobinemia, and retinopathy | ||
Unexpected | Unexpected refers to events whose nature or severity (intensity) is not consistent with those included in the package insert/summary. | ||