NCT01775475 · ADVERSE EVENTS

Adverse events

Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-Hodgkin Lymphoma · Source last updated 2022-10-10

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: 2 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (CHOP) Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies	4 / 4	4 / 4	3 / 4
Arm II (Oral Chemotherapy) Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies	3 / 3	3 / 3	3 / 3

Group identifiers: EG000: Arm I (CHOP) · EG001: Arm II (Oral Chemotherapy)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
term
Neoplasms, other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Encephalitis infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Death cause unknown

Other reported adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Blood and lymphatic system disorders, other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Blurred vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Otitis externa
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
term
Alkaline phosphatase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
GGT increased

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
4
description
Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Arm I (CHOP)
deaths Num Affected
3
deaths Num At Risk
3
description
Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Arm II (Oral Chemotherapy)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Blood and lymphatic system disorders, other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Blurred vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Otitis externa
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
term
Alkaline phosphatase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
GGT increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
term
Neoplasms, other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Encephalitis infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
3
term
Death cause unknown

time Frame

2 years

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Preserved source evidence · Not medical advice