NCT01646762 · ADVERSE EVENTS

Adverse events

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2017-10-16

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: Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years.
Other-event reporting threshold: 0%

CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Chemotherapy) Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV	11 / 13	13 / 13	1 / 13

Group identifiers: EG000: Treatment (Chemotherapy)

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
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
3
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Esophageal necrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Gastric ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Vomiting

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
13
num Events
9
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
14
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
13
num Events
10
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
3
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
13
num At Risk
13
num Events
28
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
13
num Events
7
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
term
Bronchial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
13
num Events
4
term
Aspartate aminotransferase increased

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
13
description
Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
11
serious Num At Risk
13
title
Treatment (Chemotherapy)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
13
num Events
9
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
14
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
13
num Events
10
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
3
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
13
num At Risk
13
num Events
28
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
13
num Events
7
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
term
Bronchial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
13
num Events
4
term
Aspartate aminotransferase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
3
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Duodenal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Esophageal necrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Gastric ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Gastrointestinal disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Vomiting

time Frame

Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years.

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