NCT02257242 · ADVERSE EVENTS

Adverse events

Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma · Source last updated 2023-02-09

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 event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	1 / 2	2 / 2	0 / 2
Vincristine Sulfate Liposome Injection: 2.1 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	1 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2 Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: Vincristine Sulfate Liposome Injection: 1.8 mg/m^2 · EG001: Vincristine Sulfate Liposome Injection: 1.95 mg/m^2 · EG002: Vincristine Sulfate Liposome Injection: 1.98 mg/m^2 · EG003: Vincristine Sulfate Liposome Injection: 2.04 mg/m^2 · EG004: Vincristine Sulfate Liposome Injection: 2.1 mg/m^2 · EG005: Vincristine Sulfate Liposome Injection: 2.14 mg/m^2 · EG006: Vincristine Sulfate Liposome Injection: 2.19 mg/m^2 · EG007: Vincristine Sulfate Liposome Injection: 2.22 mg/m^2 · EG008: Vincristine Sulfate Liposome Injection: 2.24 mg/m^2

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Thromboembolic Event

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
1
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
1
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
1
num At Risk
1
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
1
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
1
num At Risk
1
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
1
num At Risk
1
term
Bone pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Dehydration

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG002
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
deaths Num Affected
0
deaths Num At Risk
2
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 2.1 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG005
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG006
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG007
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
id
EG008
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
1
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
1
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
1
num At Risk
1
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
1
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
1
num At Risk
1
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
1
num At Risk
1
term
Bone pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
1
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Dehydration

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
1
group Id
EG006
num Affected
0
num At Risk
1
group Id
EG007
num Affected
0
num At Risk
1
group Id
EG008
num Affected
0
num At Risk
1
term
Thromboembolic Event

time Frame

Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice