Table 1. Data listings for patients who... | American Society of Hematology

Table 1.

Data listings for patients who developed anti-romiplostim or anti-TPO antibodies in clinical trials

Outcome
1 Romiplostim dose and cumulative romiplostim dose
2 Platelet counts over time
3 Treatment-emergent AEs of bleeding (defined as 1 or more events from MedDRA hemorrhages [Standardized MedDRA Query]) or hypersensitivity (defined as 1 or more events from the Standardized MedDRA Queries for anaphylactic reaction, anaphylactic-anaphylactoid shock conditions, angioedema or hypersensitivity) that started or worsened within 30 d after antibody detection (i.e., within 30 d of the collection date of a sample that tested positive for antibodies).
4 Proportion of weekly platelet responses (≥50 × 10⁹/L without rescue medication use in the prior 4 wk) after detection of anti-romiplostim or anti-TPO binding or neutralizing antibodies.
5 Occurrence of subsequent antibodies after detection of the first antibodies.

Outcome
1 Romiplostim dose and cumulative romiplostim dose
2 Platelet counts over time
3 Treatment-emergent AEs of bleeding (defined as 1 or more events from MedDRA hemorrhages [Standardized MedDRA Query]) or hypersensitivity (defined as 1 or more events from the Standardized MedDRA Queries for anaphylactic reaction, anaphylactic-anaphylactoid shock conditions, angioedema or hypersensitivity) that started or worsened within 30 d after antibody detection (i.e., within 30 d of the collection date of a sample that tested positive for antibodies).
4 Proportion of weekly platelet responses (≥50 × 10⁹/L without rescue medication use in the prior 4 wk) after detection of anti-romiplostim or anti-TPO binding or neutralizing antibodies.
5 Occurrence of subsequent antibodies after detection of the first antibodies.

MedDRA, Medical Dictionary for Regulatory Activities.