NCT01305200 · ADVERSE EVENTS

Adverse events

Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant · Source last updated 2019-09-17

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: 0%

Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Placebo) Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies	0 / 106	29 / 106	Not reported / Not reported
Arm II (Supersaturated Calcium Phosphate Rinse) Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies	3 / 104	22 / 104	Not reported / Not reported

Group identifiers: EG000: Arm I (Placebo) · EG001: Arm II (Supersaturated Calcium Phosphate Rinse)

Serious adverse events

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

organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Infections and infestations - Other, specify
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Intracranial hemorrhage
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Sepsis

Other reported adverse events

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

organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Allergic reaction
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Anaphylaxis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Diarrhea
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
104
term
Dysgeusia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Hypocalcemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Hypokalemia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
12
num At Risk
106
group Id
EG001
num Affected
8
num At Risk
104
term
Infections and infestations - Other, specify
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Neutrophil count decreased
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
16
num At Risk
106
group Id
EG001
num Affected
13
num At Risk
104
term
Oral pain
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Pain
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Rash acneiform
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Seizure

Complete source fields

description

Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.

event Groups

description
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
id
EG000
other Num Affected
29
other Num At Risk
106
serious Num Affected
0
serious Num At Risk
106
title
Arm I (Placebo)
description
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
id
EG001
other Num Affected
22
other Num At Risk
104
serious Num Affected
3
serious Num At Risk
104
title
Arm II (Supersaturated Calcium Phosphate Rinse)

frequency Threshold

other Events

organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Allergic reaction
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Anaphylaxis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Diarrhea
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
106
group Id
EG001
num Affected
2
num At Risk
104
term
Dysgeusia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Hypocalcemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Hypokalemia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
12
num At Risk
106
group Id
EG001
num Affected
8
num At Risk
104
term
Infections and infestations - Other, specify
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Neutrophil count decreased
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
16
num At Risk
106
group Id
EG001
num Affected
13
num At Risk
104
term
Oral pain
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Pain
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Rash acneiform
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
106
group Id
EG001
num Affected
0
num At Risk
104
term
Seizure

serious Events

organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Infections and infestations - Other, specify
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Intracranial hemorrhage
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
106
group Id
EG001
num Affected
1
num At Risk
104
term
Sepsis

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Preserved source evidence · Not medical advice