NCT00949325 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma · Source last updated 2019-03-11

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Temsirolimus Plus Liposomal Doxorubicin Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years. temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.	7 / 24	13 / 24	Not reported / Not reported

Group identifiers: EG000: Temsirolimus Plus Liposomal Doxorubicin

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
Required hospitalization.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
pneumothorax
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Plural effusion
notes
death within 30 days of ending treatment x 2 subjects
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization/feeding tube
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
required hospitalization less than 30 days post treatment.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Fever and chills

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
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Elevated transaminases
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Hyperlipedemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Pancreatitis

Complete source fields

event Groups

description
Single arm consists of temsirolimus (Torisel) plus liposomal doxorubicin (Doxil). Temsirolimus is administered IV in sequentially escalating cohorts at doses between 15 and 50 mg/M2 (body surface area), once weekly. Liposomal doxorubicin is administered IV at 30 mg per M2 (body surface area) once every 28 days. Treatment may continue with both drugs for 2 years. Temsirolimus may continue beyond 2 years. temsirolimus plus liposomal doxorubicin: Patients will be treated with temsirolimus (Torisel) temsirolimus weekly by iv and with liposomal doxorubicin (Doxil) (standard dose) by iv once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until maximally tolerated dose (MTD) is reached. Once MTD (standard dose) is achieved, dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.
id
EG000
other Num Affected
13
other Num At Risk
24
serious Num Affected
7
serious Num At Risk
24
title
Temsirolimus Plus Liposomal Doxorubicin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Elevated transaminases
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Hyperlipedemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Pancreatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
pneumothorax
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Plural effusion
notes
death within 30 days of ending treatment x 2 subjects
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Required hospitalization/feeding tube
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
required hospitalization less than 30 days post treatment.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
term
Fever and chills

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Preserved source evidence · Not medical advice