NCT00002850 · ADVERSE EVENTS

Adverse events

Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy · Source last updated 2015-11-11

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: Three months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ciprofloxacin or Ofloxacin ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.	1 / 69	1 / 69	Not reported / Not reported
TMP-SMX trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..	2 / 76	1 / 76	Not reported / Not reported
Observation No Prophylaxis: The patient will receive no prophylactic antibiotics.	0 / 67	0 / 67	Not reported / Not reported

Group identifiers: EG000: Ciprofloxacin or Ofloxacin · EG001: TMP-SMX · EG002: Observation

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized for evaluation of pain, shortness of breath, cough; death
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized for acute renal failure
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized for bacterial infection, oral thrush, allergic reaction to sulfa
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Infection, thrush, allergic reaction

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Thrush
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized with GI bleed
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
GI bleed

Complete source fields

event Groups

description
ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
id
EG000
other Num Affected
1
other Num At Risk
69
serious Num Affected
1
serious Num At Risk
69
title
Ciprofloxacin or Ofloxacin
description
trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..
id
EG001
other Num Affected
1
other Num At Risk
76
serious Num Affected
2
serious Num At Risk
76
title
TMP-SMX
description
No Prophylaxis: The patient will receive no prophylactic antibiotics.
id
EG002
other Num Affected
0
other Num At Risk
67
serious Num Affected
0
serious Num At Risk
67
title
Observation

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Thrush
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized with GI bleed
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
GI bleed

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized for evaluation of pain, shortness of breath, cough; death
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
69
group Id
EG001
num Affected
0
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized for acute renal failure
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hospitalized for bacterial infection, oral thrush, allergic reaction to sulfa
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
69
group Id
EG001
num Affected
1
num At Risk
76
group Id
EG002
num Affected
0
num At Risk
67
term
Infection, thrush, allergic reaction

time Frame

Three months.

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Preserved source evidence · Not medical advice