NCT02567435 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma · Source last updated 2026-08-28

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: Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry.
Other-event reporting threshold: 0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Regimen A (VAC/VI) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	17 / 155	139 / 155	33 / 155
Regimen B (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	77 / 153	141 / 153	33 / 153
Regimen C (FOXO1 Fusion Negative, VAC/VA) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.	0 / 3	1 / 3	0 / 3
Feasibility (VAC/VI/Temsirolimus) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.	6 / 10	8 / 10	4 / 10

Group identifiers: EG000: Regimen A (VAC/VI) · EG001: Regimen B (VAC/VI/Temsirolimus) · EG002: Regimen C (FOXO1 Fusion Negative, VAC/VA) · EG003: Feasibility (VAC/VI/Temsirolimus)

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
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
2
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
3
num At Risk
153
num Events
4
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
1
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anal mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
3
num At Risk
155
num Events
3
group Id
EG001
num Affected
6
num At Risk
153
num Events
7
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anorectal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Arthralgia

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
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
3
num At Risk
155
num Events
3
group Id
EG001
num Affected
2
num At Risk
153
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
2
group Id
EG001
num Affected
1
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
15
num At Risk
155
num Events
23
group Id
EG001
num Affected
29
num At Risk
153
num Events
36
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
2
num At Risk
155
num Events
2
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
24
num At Risk
155
num Events
31
group Id
EG001
num Affected
39
num At Risk
153
num Events
74
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
2
num At Risk
155
num Events
2
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
2
num At Risk
155
num Events
2
group Id
EG001
num Affected
7
num At Risk
153
num Events
7
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
6
num At Risk
155
num Events
7
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
9
num At Risk
155
num Events
9
group Id
EG001
num Affected
14
num At Risk
153
num Events
31
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
3
num At Risk
153
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anal fissure

Complete source fields

description

event Groups

deaths Num Affected
33
deaths Num At Risk
155
description
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
139
other Num At Risk
155
serious Num Affected
17
serious Num At Risk
155
title
Regimen A (VAC/VI)
deaths Num Affected
33
deaths Num At Risk
153
description
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
141
other Num At Risk
153
serious Num Affected
77
serious Num At Risk
153
title
Regimen B (VAC/VI/Temsirolimus)
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
1
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Regimen C (FOXO1 Fusion Negative, VAC/VA)
deaths Num Affected
4
deaths Num At Risk
10
description
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
8
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Feasibility (VAC/VI/Temsirolimus)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
3
num At Risk
155
num Events
3
group Id
EG001
num Affected
2
num At Risk
153
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
2
group Id
EG001
num Affected
1
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
15
num At Risk
155
num Events
23
group Id
EG001
num Affected
29
num At Risk
153
num Events
36
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
2
num At Risk
155
num Events
2
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
24
num At Risk
155
num Events
31
group Id
EG001
num Affected
39
num At Risk
153
num Events
74
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
2
num At Risk
155
num Events
2
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
2
num At Risk
155
num Events
2
group Id
EG001
num Affected
7
num At Risk
153
num Events
7
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
6
num At Risk
155
num Events
7
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
9
num At Risk
155
num Events
9
group Id
EG001
num Affected
14
num At Risk
153
num Events
31
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
3
num At Risk
153
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anal fissure

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
2
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
3
num At Risk
153
num Events
4
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
1
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anal mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
0
num At Risk
153
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
3
num At Risk
155
num Events
3
group Id
EG001
num Affected
6
num At Risk
153
num Events
7
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anorectal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
1
num At Risk
155
num Events
1
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCv5
stats
group Id
EG000
num Affected
0
num At Risk
155
num Events
0
group Id
EG001
num Affected
1
num At Risk
153
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Arthralgia

time Frame

Serious and Other (Not Including Serious) Adverse Events monitored/assessed up to 66 weeks from study entry. All-Cause Mortality monitored/assessed up to 7 years and 4 months from study entry.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice