NCT00822120 · ADVERSE EVENTS

Adverse events

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma · Source last updated 2022-08-18

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: Up to 1 year
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
HIV-negative: Initial ABVD Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles	1 / 336	335 / 336	Not reported / Not reported
HIV-negative and PET-negative: Continued ABVD Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles	6 / 270	268 / 270	Not reported / Not reported
HIV-negative and PET-positive: BEACOPP Escalated Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles	2 / 49	49 / 49	Not reported / Not reported
HIV-positive: Initial ABVD Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles	1 / 12	12 / 12	Not reported / Not reported
HIV-positive and PET-negative: Continued ABVD Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles	0 / 10	9 / 10	Not reported / Not reported
HIV-positive and PET-positive: BEACOPP Standard Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles	0 / 1	1 / 1	Not reported / Not reported

Group identifiers: EG000: HIV-negative: Initial ABVD · EG001: HIV-negative and PET-negative: Continued ABVD · EG002: HIV-negative and PET-positive: BEACOPP Escalated · EG003: HIV-positive: Initial ABVD · EG004: HIV-positive and PET-negative: Continued ABVD · EG005: HIV-positive and PET-positive: BEACOPP Standard

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
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 (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Infection with unknown ANC - Lung (pneumonia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Sodium, serum-low (hyponatremia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Mood alteration - agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Mood alteration - depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Pneumonitis/pulmonary infiltrates

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 (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
336
group Id
EG001
num Affected
17
num At Risk
270
group Id
EG002
num Affected
16
num At Risk
49
group Id
EG003
num Affected
3
num At Risk
12
group Id
EG004
num Affected
3
num At Risk
10
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 (3.0)
stats
group Id
EG000
num Affected
171
num At Risk
336
group Id
EG001
num Affected
161
num At Risk
270
group Id
EG002
num Affected
44
num At Risk
49
group Id
EG003
num Affected
6
num At Risk
12
group Id
EG004
num Affected
7
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
336
group Id
EG001
num Affected
4
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
336
group Id
EG001
num Affected
9
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
SVT and nodal arrhythmia - Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
336
group Id
EG001
num Affected
15
num At Risk
270
group Id
EG002
num Affected
2
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
1
term
Ocular/Visual-Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
114
num At Risk
336
group Id
EG001
num Affected
73
num At Risk
270
group Id
EG002
num Affected
10
num At Risk
49
group Id
EG003
num Affected
5
num At Risk
12
group Id
EG004
num Affected
2
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Dental: teeth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
34
num At Risk
336
group Id
EG001
num Affected
40
num At Risk
270
group Id
EG002
num Affected
15
num At Risk
49
group Id
EG003
num Affected
3
num At Risk
12
group Id
EG004
num Affected
5
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
336
group Id
EG001
num Affected
2
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Dysphagia (difficulty swallowing)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
336
group Id
EG001
num Affected
4
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Gastritis (including bile reflux gastritis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
28
num At Risk
336
group Id
EG001
num Affected
30
num At Risk
270
group Id
EG002
num Affected
5
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Heartburn/dyspepsia

Complete source fields

event Groups

description
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
id
EG000
other Num Affected
335
other Num At Risk
336
serious Num Affected
1
serious Num At Risk
336
title
HIV-negative: Initial ABVD
description
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
id
EG001
other Num Affected
268
other Num At Risk
270
serious Num Affected
6
serious Num At Risk
270
title
HIV-negative and PET-negative: Continued ABVD
description
Etoposide 200 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m\^2 IV Day 1, Cyclophosphamide 1,250 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
id
EG002
other Num Affected
49
other Num At Risk
49
serious Num Affected
2
serious Num At Risk
49
title
HIV-negative and PET-positive: BEACOPP Escalated
description
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 2 cycles
id
EG003
other Num Affected
12
other Num At Risk
12
serious Num Affected
1
serious Num At Risk
12
title
HIV-positive: Initial ABVD
description
Doxorubicin 25 mg/m\^2 IV, Bleomycin 10u/m\^2 IV, Vinblastine 6mg/m\^2 IV, Dacarbazine 375 mg/m\^2 IV Days 1,15 Q 28 Days x 4 cycles
id
EG004
other Num Affected
9
other Num At Risk
10
serious Num Affected
0
serious Num At Risk
10
title
HIV-positive and PET-negative: Continued ABVD
description
Etoposide 100 mg/m\^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m\^2 IV Day 1, Cyclophosphamide 650 mg/m\^2 IV Day 1, Procarbzine 100 mg/m\^2 PO Days 1-7, Prednisone 40 mg/m\^2 PO Days 1-14, Bleomycin 10u/m\^2 IV Day 8, Vincristine 1.4 mg/m\^2 IV Day 8, Q 21 Days x 6 cycles
id
EG005
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
HIV-positive and PET-positive: BEACOPP Standard

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
336
group Id
EG001
num Affected
17
num At Risk
270
group Id
EG002
num Affected
16
num At Risk
49
group Id
EG003
num Affected
3
num At Risk
12
group Id
EG004
num Affected
3
num At Risk
10
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 (3.0)
stats
group Id
EG000
num Affected
171
num At Risk
336
group Id
EG001
num Affected
161
num At Risk
270
group Id
EG002
num Affected
44
num At Risk
49
group Id
EG003
num Affected
6
num At Risk
12
group Id
EG004
num Affected
7
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
336
group Id
EG001
num Affected
4
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
336
group Id
EG001
num Affected
9
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
SVT and nodal arrhythmia - Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
336
group Id
EG001
num Affected
15
num At Risk
270
group Id
EG002
num Affected
2
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
1
num At Risk
1
term
Ocular/Visual-Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
114
num At Risk
336
group Id
EG001
num Affected
73
num At Risk
270
group Id
EG002
num Affected
10
num At Risk
49
group Id
EG003
num Affected
5
num At Risk
12
group Id
EG004
num Affected
2
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Dental: teeth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
34
num At Risk
336
group Id
EG001
num Affected
40
num At Risk
270
group Id
EG002
num Affected
15
num At Risk
49
group Id
EG003
num Affected
3
num At Risk
12
group Id
EG004
num Affected
5
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
336
group Id
EG001
num Affected
2
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Dysphagia (difficulty swallowing)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
336
group Id
EG001
num Affected
4
num At Risk
270
group Id
EG002
num Affected
3
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Gastritis (including bile reflux gastritis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
28
num At Risk
336
group Id
EG001
num Affected
30
num At Risk
270
group Id
EG002
num Affected
5
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Heartburn/dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
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 (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Infection with unknown ANC - Lung (pneumonia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Sodium, serum-low (hyponatremia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Mood alteration - agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
0
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Mood alteration - depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
0
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
336
group Id
EG001
num Affected
1
num At Risk
270
group Id
EG002
num Affected
1
num At Risk
49
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
1
term
Pneumonitis/pulmonary infiltrates

time Frame

Up to 1 year

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

Preserved source evidence · Not medical advice