NCT00081939 · ADVERSE EVENTS

Adverse events

UARK 2003-33, Total Therapy III · Source last updated 2017-10-17

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Study Treatment Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.	303 / 303	303 / 303	Not reported / Not reported

Group identifiers: EG000: Study Treatment

Serious 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
7
num At Risk
303
term
Grade 3 Allergic reaction/hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
303
term
Grade 4 Allergic reaction/Hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 4 Allergy-other
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 3 Autoimmune reaction
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
4
num At Risk
303
term
Grade 3 Hearing
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
139
num At Risk
303
term
Grade 3 Anemia (HGB)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
48
num At Risk
303
term
Grade 4 Anemia (HGB)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 3 CD4 count
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 3 Lymphopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
303
term
Grade 3 Neutropenia/granulocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
115
num At Risk
303
term
Grade 4 Neutropenia/granulocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
303
term
Grade 3 Thrombocytopenia (PLT)

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
69
num At Risk
303
term
Grade 1 Allergic reaction/hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
27
num At Risk
303
term
Grade 2 Allergic reaction/hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
43
num At Risk
303
term
Grade 1 Rhinitis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
19
num At Risk
303
term
Grade 2 Rhinitis
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
16
num At Risk
303
term
Grade 1 Auditory/ear-other
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
16
num At Risk
303
term
Grade 2 Hearing w/o monitoring program
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
31
num At Risk
303
term
Grade 2 Tinnitus
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
112
num At Risk
303
term
Grade 2 Anemia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
52
num At Risk
303
term
Grade 1 Ventricular Arrythmia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
58
num At Risk
303
term
Grade 2 Ventricular Arrythmia
organ System
General disorders
stats
group Id
EG000
num Affected
48
num At Risk
303
term
Grade 1 Constitutional symptoms-other
organ System
General disorders
stats
group Id
EG000
num Affected
17
num At Risk
303
term
Grade 2 Constitutional symptoms-other

Complete source fields

event Groups

description
Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
id
EG000
other Num Affected
303
other Num At Risk
303
serious Num Affected
303
serious Num At Risk
303
title
Study Treatment

frequency Threshold

other Events

organ System
Immune system disorders
stats
group Id
EG000
num Affected
69
num At Risk
303
term
Grade 1 Allergic reaction/hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
27
num At Risk
303
term
Grade 2 Allergic reaction/hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
43
num At Risk
303
term
Grade 1 Rhinitis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
19
num At Risk
303
term
Grade 2 Rhinitis
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
16
num At Risk
303
term
Grade 1 Auditory/ear-other
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
16
num At Risk
303
term
Grade 2 Hearing w/o monitoring program
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
31
num At Risk
303
term
Grade 2 Tinnitus
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
112
num At Risk
303
term
Grade 2 Anemia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
52
num At Risk
303
term
Grade 1 Ventricular Arrythmia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
58
num At Risk
303
term
Grade 2 Ventricular Arrythmia
organ System
General disorders
stats
group Id
EG000
num Affected
48
num At Risk
303
term
Grade 1 Constitutional symptoms-other
organ System
General disorders
stats
group Id
EG000
num Affected
17
num At Risk
303
term
Grade 2 Constitutional symptoms-other

serious Events

organ System
Immune system disorders
stats
group Id
EG000
num Affected
7
num At Risk
303
term
Grade 3 Allergic reaction/hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
303
term
Grade 4 Allergic reaction/Hypersensitivity
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 4 Allergy-other
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 3 Autoimmune reaction
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
4
num At Risk
303
term
Grade 3 Hearing
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
139
num At Risk
303
term
Grade 3 Anemia (HGB)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
48
num At Risk
303
term
Grade 4 Anemia (HGB)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 3 CD4 count
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
303
term
Grade 3 Lymphopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
4
num At Risk
303
term
Grade 3 Neutropenia/granulocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
115
num At Risk
303
term
Grade 4 Neutropenia/granulocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
303
term
Grade 3 Thrombocytopenia (PLT)

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