NCT02464228 · ADVERSE EVENTS

Adverse events

Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy · Source last updated 2024-06-26

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 approximately 3 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort AITL Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.	21 / 38	38 / 38	13 / 38
Cohort PTCL-NOS Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.	8 / 14	14 / 14	8 / 14
Cohort PTCL-NOS, CXCL12+ Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.	8 / 11	11 / 11	4 / 11
Cohort Other Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.	1 / 2	2 / 2	1 / 2

Group identifiers: EG000: Cohort AITL · EG001: Cohort PTCL-NOS · EG002: Cohort PTCL-NOS, CXCL12+ · EG003: Cohort Other

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Acute myeloid leukaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Myelodysplastic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Squamous cell carcinoma of lung
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
38
group Id
EG001
num Affected
3
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Confusional state
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Overdose

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
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
8
num At Risk
38
group Id
EG001
num Affected
2
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Peripheral coldness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
3
num At Risk
38
group Id
EG001
num Affected
3
num At Risk
14
group Id
EG002
num Affected
3
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
11
group Id
EG003
num Affected
1
num At Risk
2
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
19
num At Risk
38
group Id
EG001
num Affected
7
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Decreased activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Influenza like illness

Complete source fields

event Groups

deaths Num Affected
13
deaths Num At Risk
38
description
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
id
EG000
other Num Affected
38
other Num At Risk
38
serious Num Affected
21
serious Num At Risk
38
title
Cohort AITL
deaths Num Affected
8
deaths Num At Risk
14
description
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
id
EG001
other Num Affected
14
other Num At Risk
14
serious Num Affected
8
serious Num At Risk
14
title
Cohort PTCL-NOS
deaths Num Affected
4
deaths Num At Risk
11
description
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
id
EG002
other Num Affected
11
other Num At Risk
11
serious Num Affected
8
serious Num At Risk
11
title
Cohort PTCL-NOS, CXCL12+
deaths Num Affected
1
deaths Num At Risk
2
description
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Cohort Other

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
8
num At Risk
38
group Id
EG001
num Affected
2
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Peripheral coldness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
3
num At Risk
38
group Id
EG001
num Affected
3
num At Risk
14
group Id
EG002
num Affected
3
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
11
group Id
EG003
num Affected
1
num At Risk
2
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
19
num At Risk
38
group Id
EG001
num Affected
7
num At Risk
14
group Id
EG002
num Affected
2
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Decreased activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Influenza like illness

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Acute myeloid leukaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Myelodysplastic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Squamous cell carcinoma of lung
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
38
group Id
EG001
num Affected
3
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Confusional state
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
38
group Id
EG001
num Affected
1
num At Risk
14
group Id
EG002
num Affected
0
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
38
group Id
EG001
num Affected
0
num At Risk
14
group Id
EG002
num Affected
1
num At Risk
11
group Id
EG003
num Affected
0
num At Risk
2
term
Overdose

time Frame

Up to approximately 3 years

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

Preserved source evidence · Not medical advice