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NCT01066624 · ADVERSE EVENTS

Adverse events

Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation · Source last updated 2015-07-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
0.9% Sodium Chloride Irrigation Solution

Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study. 0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study

0 / 380 / 38Not reported / Not reported
Cryotherapy (Ice Chips)

Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.

0 / 400 / 40Not reported / Not reported
Calcium Phosphate (Caphosol) Mouth Rinse

Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study. Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.

0 / 390 / 39Not reported / Not reported

Group identifiers: EG000: 0.9% Sodium Chloride Irrigation Solution · EG001: Cryotherapy (Ice Chips) · EG002: Calcium Phosphate (Caphosol) Mouth Rinse

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. description
        Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study. 0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        38
        serious Num Affected
        0
        serious Num At Risk
        38
        title
        0.9% Sodium Chloride Irrigation Solution
      2. description
        Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        40
        serious Num Affected
        0
        serious Num At Risk
        40
        title
        Cryotherapy (Ice Chips)
      3. description
        Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study. Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        39
        serious Num Affected
        0
        serious Num At Risk
        39
        title
        Calcium Phosphate (Caphosol) Mouth Rinse
      frequency Threshold
      5

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice