Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

Time to Achieve a Clinical Response

A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.

Time frame: Day 2 to Day 7

Maximum Platelet Count

Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.

Time frame: Day 2 to the end of the study (Day 63)

Duration of the Clinical Response

The duration of the clinical response was the number of days that the platelet count remained ≥ 50\*10\^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50\*10\^9/L on Day 7 and dropped below 50\*10\^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50\*10\^9/L at Day 21 from Day 14 or Day 63 from Day 21.

Time frame: Day 2 to the end of the study (Day 63)

Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7

The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae \[≤ 100 total\] and/or ≤ 5 small bruises \[≤ 3 cm diameter\], no mucosal bleeding), Mild (many petechiae \[\> 100 total\] and/or \> 5 large bruises \[\> 3 cm diameter\], no mucosal bleeding), Moderate (overt mucosal bleeding \[epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc\] that does not require immediate medical attention or intervention).