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Trial · NCT04680195

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRemission rate of rectal bleeding one month after thalidomide treatmentthe first month after thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryRemission rate of rectal bleeding one month during thalidomide treatmentthe first month during thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryRemission rate of rectal bleeding two months during thalidomide treatmentthe second month during thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryRemission rate of rectal bleeding three months during thalidomide treatmentthe third month during thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryRemission rate of rectal bleeding four months during thalidomide treatmentthe fourth month during thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryRemission rate of rectal bleeding three months after thalidomide treatmentthe third month after thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryRemission rate of rectal bleeding six months after thalidomide treatmentthe sixth month after thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
SecondaryEndoscopic score one month during thalidomide treatmentthe first month during thalidomide treatmentEndoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
SecondaryEndoscopic score four months during thalidomide treatmentthe fourth month during thalidomide treatmentEndoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
SecondaryEndoscopic score one month after thalidomide treatmentthe first month after thalidomide treatmentEndoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
SecondaryEndoscopic score three months after thalidomide treatmentthe third month after thalidomide treatmentEndoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
SecondaryEndoscopic score six months after thalidomide treatmentthe sixth month after thalidomide treatmentEndoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
SecondaryQuality of life of the patient one month during thalidomide treatmentthe first month during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item questionnaire composed of multi-item scales and single items that reflect the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryQuality of life of the patient two months during thalidomide treatmentthe second month during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryQuality of life of the patient three months during thalidomide treatmentthe third month during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryQuality of life of the patient four months during thalidomide treatmentthe fourth month during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryQuality of life of the patient one month after thalidomide treatmentthe first month after thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryQuality of life of the patient three months after thalidomide treatmentthe third month after thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryQuality of life of the patient six months after thalidomide treatmentthe sixth month after thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
SecondaryIncidence of adverse events four months during thalidomide treatmentthe fourth month during thalidomide treatmentIncluding adverse reactions of thalidomide and other adverse events

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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