NCT00831844 · ADVERSE EVENTS

Adverse events

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors · Source last updated 2015-03-30

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: Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).
Other-event reporting threshold: 0%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1 - Recurrent or Refractory Hepatoblastoma Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	7 / 10	5 / 10	Not reported / Not reported
Group 2 - Recurrent or Refractory Synovial Sarcoma Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	3 / 10	7 / 10	Not reported / Not reported
Group 3 - Recurrent or Refractory Rhabdomyosarcoma Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	4 / 20	14 / 20	Not reported / Not reported
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5 / 10	5 / 10	Not reported / Not reported
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5 / 13	8 / 13	Not reported / Not reported
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5 / 20	9 / 20	Not reported / Not reported
Grp 7-Neuroblastoma With Measurable Disease Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	4 / 10	9 / 10	Not reported / Not reported
Group 8 - Recurrent Osteosarcoma Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	4 / 9	5 / 9	Not reported / Not reported
Group 9 - Recurrent or Refractory Wilms Tumor Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	5 / 9	9 / 9	Not reported / Not reported
Group 10 - Recurrent or Refractory Retinoblastoma Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	0 / 0	0 / 0	Not reported / Not reported

Group identifiers: EG000: Group 1 - Recurrent or Refractory Hepatoblastoma · EG001: Group 2 - Recurrent or Refractory Synovial Sarcoma · EG002: Group 3 - Recurrent or Refractory Rhabdomyosarcoma · EG003: Grp 4-Recurrent or Refractory Adrenocortical Carcinoma · EG004: Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor · EG005: Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease · EG006: Grp 7-Neuroblastoma With Measurable Disease · EG007: Group 8 - Recurrent Osteosarcoma · EG008: Group 9 - Recurrent or Refractory Wilms Tumor · EG009: Group 10 - Recurrent or Refractory Retinoblastoma

Serious adverse events

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

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Abdominal pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Alanine aminotransferase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anorexia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Appendicitis
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Aspartate aminotransferase increased
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Asystole
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
1
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Back pain
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Bladder infection
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Chest wall pain

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
1
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Abdominal pain
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
3
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Alanine aminotransferase increased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Alkaline phosphatase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Allergic reaction
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Allergic rhinitis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
4
num At Risk
20
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
13
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
9
group Id
EG008
num Affected
2
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
1
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anorexia
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anxiety
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Arthralgia
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Aspartate aminotransferase increased
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Atelectasis

Complete source fields

description

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

event Groups

description
Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
5
other Num At Risk
10
serious Num Affected
7
serious Num At Risk
10
title
Group 1 - Recurrent or Refractory Hepatoblastoma
description
Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
7
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
Group 2 - Recurrent or Refractory Synovial Sarcoma
description
Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG002
other Num Affected
14
other Num At Risk
20
serious Num Affected
4
serious Num At Risk
20
title
Group 3 - Recurrent or Refractory Rhabdomyosarcoma
description
Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG003
other Num Affected
5
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
description
Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG004
other Num Affected
8
other Num At Risk
13
serious Num Affected
5
serious Num At Risk
13
title
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
description
Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG005
other Num Affected
9
other Num At Risk
20
serious Num Affected
5
serious Num At Risk
20
title
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
description
Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG006
other Num Affected
9
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Grp 7-Neuroblastoma With Measurable Disease
description
Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG007
other Num Affected
5
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Group 8 - Recurrent Osteosarcoma
description
Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG008
other Num Affected
9
other Num At Risk
9
serious Num Affected
5
serious Num At Risk
9
title
Group 9 - Recurrent or Refractory Wilms Tumor
description
Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
id
EG009
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group 10 - Recurrent or Refractory Retinoblastoma

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
1
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Abdominal pain
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
3
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Alanine aminotransferase increased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Alkaline phosphatase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Allergic reaction
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Allergic rhinitis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
4
num At Risk
20
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
13
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
9
group Id
EG008
num Affected
2
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
1
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anorexia
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anxiety
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Arthralgia
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Aspartate aminotransferase increased
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Atelectasis

serious Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Abdominal pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Alanine aminotransferase increased
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Anorexia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Appendicitis
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Aspartate aminotransferase increased
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Asystole
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
1
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Back pain
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Bladder infection
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
10
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
20
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
9
group Id
EG008
num Affected
0
num At Risk
9
group Id
EG009
num Affected
0
num At Risk
0
term
Chest wall pain

time Frame

Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).

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

Preserved source evidence · Not medical advice