Trial Outcomes & Findings for Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions (NCT NCT00872833)

Results Overview

Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

measured daily over the 3 transfusion cycles

Results posted on

2015-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	Younger Cohort People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.	Older Cohort People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
Overall Study STARTED	15	17
Overall Study COMPLETED	15	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=32 Participants Both cohorts combined
Age, Continuous	31.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: measured daily over the 3 transfusion cycles

Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.

Outcome measures

Outcome measures
Measure	Younger Cohort n=40 Participant-cycles People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.	Older Cohort n=43 Participant-cycles People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.	22 - 28 Days Subjects with transfusion cycles between 22 and 28 days	> 28 Days Subjects with transfusion cycles greater than 28 days
Report of Pain by Age Group Start of cycle	23 percentage of participant-cycles	61 percentage of participant-cycles	—	—
Report of Pain by Age Group 25% through cycle	18 percentage of participant-cycles	51 percentage of participant-cycles	—	—
Report of Pain by Age Group 50% through cycle	15 percentage of participant-cycles	47 percentage of participant-cycles	—	—
Report of Pain by Age Group 75% through cycle	20 percentage of participant-cycles	54 percentage of participant-cycles	—	—
Report of Pain by Age Group End of cycle	18 percentage of participant-cycles	56 percentage of participant-cycles	—	—

SECONDARY outcome

Timeframe: measured daily over the 3 transfusion cycles

Population: Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.

Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.

Outcome measures

Outcome measures
Measure	Younger Cohort n=10 Participant-cycles People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.	Older Cohort n=25 Participant-cycles People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.	22 - 28 Days n=26 Participant-cycles Subjects with transfusion cycles between 22 and 28 days	> 28 Days n=22 Participant-cycles Subjects with transfusion cycles greater than 28 days
Report of Pain by Length of the Transfusion Cycle End of cycle	50 percentage of participant-cycles	44 percentage of participant-cycles	31 percentage of participant-cycles	32 percentage of participant-cycles
Report of Pain by Length of the Transfusion Cycle Start of cycle	50 percentage of participant-cycles	40 percentage of participant-cycles	42 percentage of participant-cycles	41 percentage of participant-cycles
Report of Pain by Length of the Transfusion Cycle 25% through cycle	50 percentage of participant-cycles	48 percentage of participant-cycles	35 percentage of participant-cycles	14 percentage of participant-cycles
Report of Pain by Length of the Transfusion Cycle 50% through cycle	50 percentage of participant-cycles	48 percentage of participant-cycles	23 percentage of participant-cycles	14 percentage of participant-cycles
Report of Pain by Length of the Transfusion Cycle 75% through cycle	60 percentage of participant-cycles	52 percentage of participant-cycles	31 percentage of participant-cycles	18 percentage of participant-cycles

Adverse Events

Adverse Events Were Not Collected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Gerstenberger

New England Research Institutes, Inc.

Phone: 6179237747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place