NCT01274338 · ADVERSE EVENTS

Adverse events

Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery · Source last updated 2026-09-08

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: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
Other-event reporting threshold: 5%

Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (HIP) Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.	292 / 503	495 / 503	153 / 511
Arm B (HDI) Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.	410 / 520	510 / 520	168 / 636
Arm C (LIP) Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.	197 / 516	488 / 516	135 / 523
Arm D (HIP; Pediatric) Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.	0 / 1	0 / 1	0 / 1
Arm E (HDI; Pediatric) Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.	0 / 1	0 / 1	0 / 1
Arm F (LIP; Pediatric) Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.	0 / 1	0 / 1	0 / 1

Group identifiers: EG000: Arm A (HIP) · EG001: Arm B (HDI) · EG002: Arm C (LIP) · EG003: Arm D (HIP; Pediatric) · EG004: Arm E (HDI; Pediatric) · EG005: Arm F (LIP; Pediatric)

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
Ear and labyrinth disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
2
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Vestibular disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
503
group Id
EG001
num Affected
4
num At Risk
520
group Id
EG002
num Affected
5
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Blood and lymphatic disorders - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
2
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Heart failure

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
90
num At Risk
503
group Id
EG001
num Affected
209
num At Risk
520
group Id
EG002
num Affected
69
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
61
num At Risk
503
group Id
EG001
num Affected
178
num At Risk
520
group Id
EG002
num Affected
34
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
328
num At Risk
503
group Id
EG001
num Affected
456
num At Risk
520
group Id
EG002
num Affected
298
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
98
num At Risk
503
group Id
EG001
num Affected
174
num At Risk
520
group Id
EG002
num Affected
53
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
39
num At Risk
503
group Id
EG001
num Affected
254
num At Risk
520
group Id
EG002
num Affected
34
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
10
num At Risk
503
group Id
EG001
num Affected
31
num At Risk
520
group Id
EG002
num Affected
6
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
503
group Id
EG001
num Affected
31
num At Risk
520
group Id
EG002
num Affected
11
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
11
num At Risk
503
group Id
EG001
num Affected
115
num At Risk
520
group Id
EG002
num Affected
8
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
23
num At Risk
503
group Id
EG001
num Affected
51
num At Risk
520
group Id
EG002
num Affected
17
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
226
num At Risk
503
group Id
EG001
num Affected
84
num At Risk
520
group Id
EG002
num Affected
215
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
281
num At Risk
503
group Id
EG001
num Affected
98
num At Risk
520
group Id
EG002
num Affected
229
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
27
num At Risk
503
group Id
EG001
num Affected
35
num At Risk
520
group Id
EG002
num Affected
19
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Skin and subcutaneous tissue - Other

Complete source fields

description

Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

event Groups

deaths Num Affected
153
deaths Num At Risk
511
description
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
495
other Num At Risk
503
serious Num Affected
292
serious Num At Risk
503
title
Arm A (HIP)
deaths Num Affected
168
deaths Num At Risk
636
description
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
510
other Num At Risk
520
serious Num Affected
410
serious Num At Risk
520
title
Arm B (HDI)
deaths Num Affected
135
deaths Num At Risk
523
description
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
488
other Num At Risk
516
serious Num Affected
197
serious Num At Risk
516
title
Arm C (LIP)
deaths Num Affected
0
deaths Num At Risk
1
description
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Arm D (HIP; Pediatric)
deaths Num Affected
0
deaths Num At Risk
1
description
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Arm E (HDI; Pediatric)
deaths Num Affected
0
deaths Num At Risk
1
description
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
id
EG005
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Arm F (LIP; Pediatric)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
90
num At Risk
503
group Id
EG001
num Affected
209
num At Risk
520
group Id
EG002
num Affected
69
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
61
num At Risk
503
group Id
EG001
num Affected
178
num At Risk
520
group Id
EG002
num Affected
34
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
328
num At Risk
503
group Id
EG001
num Affected
456
num At Risk
520
group Id
EG002
num Affected
298
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
98
num At Risk
503
group Id
EG001
num Affected
174
num At Risk
520
group Id
EG002
num Affected
53
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
39
num At Risk
503
group Id
EG001
num Affected
254
num At Risk
520
group Id
EG002
num Affected
34
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
10
num At Risk
503
group Id
EG001
num Affected
31
num At Risk
520
group Id
EG002
num Affected
6
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
503
group Id
EG001
num Affected
31
num At Risk
520
group Id
EG002
num Affected
11
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
11
num At Risk
503
group Id
EG001
num Affected
115
num At Risk
520
group Id
EG002
num Affected
8
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
23
num At Risk
503
group Id
EG001
num Affected
51
num At Risk
520
group Id
EG002
num Affected
17
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
226
num At Risk
503
group Id
EG001
num Affected
84
num At Risk
520
group Id
EG002
num Affected
215
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
281
num At Risk
503
group Id
EG001
num Affected
98
num At Risk
520
group Id
EG002
num Affected
229
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
27
num At Risk
503
group Id
EG001
num Affected
35
num At Risk
520
group Id
EG002
num Affected
19
num At Risk
516
group Id
EG003
num At Risk
1
group Id
EG004
num At Risk
1
group Id
EG005
num At Risk
1
term
Skin and subcutaneous tissue - Other

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
2
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Vestibular disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
503
group Id
EG001
num Affected
4
num At Risk
520
group Id
EG002
num Affected
5
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Blood and lymphatic disorders - Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
0
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
503
group Id
EG001
num Affected
1
num At Risk
520
group Id
EG002
num Affected
1
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
503
group Id
EG001
num Affected
2
num At Risk
520
group Id
EG002
num Affected
0
num At Risk
516
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
1
term
Heart failure

time Frame

Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years

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

Preserved source evidence · Not medical advice