| Adverse Event of Special Interest . | Investigational Product . | Objective Measure . |
|---|---|---|
| Gastrointestinal hemorrhage | Aspirin | Clinical and laboratory measures to suggest hemorrhage |
| Intracerebral hemorrhage | Aspirin | Radiological evidence of hemorrhage |
| Transaminitis | Rifampicin | Alanine transaminase, bilirubin (DAIDS criteria, grades 3 and 4) |
| Anemia | Linezolid | Hemoglobin (DAIDS criteria, grades 3 and 4) |
| Neutropenia | Linezolid | Neutrophils (DAIDS criteria, grades 3 and 4) |
| Thrombocytopenia | Linezolid | Platelet count (DAIDS criteria, grades 3 and 4) |
| Peripheral neuropathy | Linezolid | 1 grade increase on the brief peripheral neuropathy score and/or a 2 grade change in any modality on the modified total neuropathy score |
| Change in logarithm of the minimum angle of resolution score (visual acuity) | Linezolid | Change of 0.2 on the logarithm of the minimum angle of resolution/tumbling E chart |
| Adverse Event of Special Interest . | Investigational Product . | Objective Measure . |
|---|---|---|
| Gastrointestinal hemorrhage | Aspirin | Clinical and laboratory measures to suggest hemorrhage |
| Intracerebral hemorrhage | Aspirin | Radiological evidence of hemorrhage |
| Transaminitis | Rifampicin | Alanine transaminase, bilirubin (DAIDS criteria, grades 3 and 4) |
| Anemia | Linezolid | Hemoglobin (DAIDS criteria, grades 3 and 4) |
| Neutropenia | Linezolid | Neutrophils (DAIDS criteria, grades 3 and 4) |
| Thrombocytopenia | Linezolid | Platelet count (DAIDS criteria, grades 3 and 4) |
| Peripheral neuropathy | Linezolid | 1 grade increase on the brief peripheral neuropathy score and/or a 2 grade change in any modality on the modified total neuropathy score |
| Change in logarithm of the minimum angle of resolution score (visual acuity) | Linezolid | Change of 0.2 on the logarithm of the minimum angle of resolution/tumbling E chart |
Abbreviation: DAIDS, Division of AIDS.
| Adverse Event of Special Interest . | Investigational Product . | Objective Measure . |
|---|---|---|
| Gastrointestinal hemorrhage | Aspirin | Clinical and laboratory measures to suggest hemorrhage |
| Intracerebral hemorrhage | Aspirin | Radiological evidence of hemorrhage |
| Transaminitis | Rifampicin | Alanine transaminase, bilirubin (DAIDS criteria, grades 3 and 4) |
| Anemia | Linezolid | Hemoglobin (DAIDS criteria, grades 3 and 4) |
| Neutropenia | Linezolid | Neutrophils (DAIDS criteria, grades 3 and 4) |
| Thrombocytopenia | Linezolid | Platelet count (DAIDS criteria, grades 3 and 4) |
| Peripheral neuropathy | Linezolid | 1 grade increase on the brief peripheral neuropathy score and/or a 2 grade change in any modality on the modified total neuropathy score |
| Change in logarithm of the minimum angle of resolution score (visual acuity) | Linezolid | Change of 0.2 on the logarithm of the minimum angle of resolution/tumbling E chart |
| Adverse Event of Special Interest . | Investigational Product . | Objective Measure . |
|---|---|---|
| Gastrointestinal hemorrhage | Aspirin | Clinical and laboratory measures to suggest hemorrhage |
| Intracerebral hemorrhage | Aspirin | Radiological evidence of hemorrhage |
| Transaminitis | Rifampicin | Alanine transaminase, bilirubin (DAIDS criteria, grades 3 and 4) |
| Anemia | Linezolid | Hemoglobin (DAIDS criteria, grades 3 and 4) |
| Neutropenia | Linezolid | Neutrophils (DAIDS criteria, grades 3 and 4) |
| Thrombocytopenia | Linezolid | Platelet count (DAIDS criteria, grades 3 and 4) |
| Peripheral neuropathy | Linezolid | 1 grade increase on the brief peripheral neuropathy score and/or a 2 grade change in any modality on the modified total neuropathy score |
| Change in logarithm of the minimum angle of resolution score (visual acuity) | Linezolid | Change of 0.2 on the logarithm of the minimum angle of resolution/tumbling E chart |
Abbreviation: DAIDS, Division of AIDS.
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