NCT02207556 · ADVERSE EVENTS

Adverse events

Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial · Source last updated 2021-07-09

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: 1 year
Other-event reporting threshold: 5%

Grade was determined using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. Events graded as 4 or 5 were considered serious regardless of the standard criteria.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Doxycycline (Localized Disease) Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.	1 / 5	5 / 5	0 / 5
Doxycycline (Systemic Disease) Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.	13 / 25	24 / 25	5 / 25

Group identifiers: EG000: Doxycycline (Localized Disease) · EG001: Doxycycline (Systemic Disease)

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
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
7
num At Risk
25
num Events
7
term
Lymphocyte production decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
6
num At Risk
25
num Events
6
term
Neutrophil Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
10
num At Risk
25
num Events
10
term
Platelet Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
5
num At Risk
25
num Events
5
term
White Blood Cell Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Hyperuricemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Infections and infestations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Adenovirus Infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Chronic Kidney Disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 5
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Progressive cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 5
organ System
Blood and lymphatic system disorders
source Vocabulary
SNOMED
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Death in Hospice
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 5
organ System
Cardiac disorders
source Vocabulary
SNOMED
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Natural Death
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
SNOMED
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Thrombosis of Vein of Lower Limb
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Aspartate Aminotransferase Increased

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
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
15
num At Risk
25
num Events
15
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
6
num At Risk
25
num Events
6
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
5
num At Risk
25
num Events
5
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
8
num At Risk
25
num Events
8
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
12
num At Risk
25
num Events
12
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
15
num At Risk
25
num Events
15
term
Edema, Limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
6
num At Risk
25
num Events
6
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
17
num At Risk
25
num Events
17
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Hyperuricemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
16
num At Risk
25
num Events
16
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
14
num At Risk
25
num Events
14
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
8
num At Risk
25
num Events
8
term
Pain

Complete source fields

description

Grade was determined using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. Events graded as 4 or 5 were considered serious regardless of the standard criteria.

event Groups

deaths Num Affected
0
deaths Num At Risk
5
description
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Doxycycline (Localized Disease)
deaths Num Affected
5
deaths Num At Risk
25
description
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
id
EG001
other Num Affected
24
other Num At Risk
25
serious Num Affected
13
serious Num At Risk
25
title
Doxycycline (Systemic Disease)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
15
num At Risk
25
num Events
15
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
6
num At Risk
25
num Events
6
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
5
num At Risk
25
num Events
5
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
8
num At Risk
25
num Events
8
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
12
num At Risk
25
num Events
12
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
15
num At Risk
25
num Events
15
term
Edema, Limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
6
num At Risk
25
num Events
6
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
17
num At Risk
25
num Events
17
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Hyperuricemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
16
num At Risk
25
num Events
16
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
14
num At Risk
25
num Events
14
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
8
num At Risk
25
num Events
8
term
Pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
7
num At Risk
25
num Events
7
term
Lymphocyte production decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
6
num At Risk
25
num Events
6
term
Neutrophil Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
10
num At Risk
25
num Events
10
term
Platelet Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
5
num At Risk
25
num Events
5
term
White Blood Cell Count Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Hyperuricemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Infections and infestations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Adenovirus Infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Chronic Kidney Disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 5
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Progressive cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 5
organ System
Blood and lymphatic system disorders
source Vocabulary
SNOMED
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Death in Hospice
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 5
organ System
Cardiac disorders
source Vocabulary
SNOMED
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Natural Death
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Blood and lymphatic system disorders
source Vocabulary
SNOMED
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Thrombosis of Vein of Lower Limb
assessment Type
SYSTEMATIC_ASSESSMENT
notes
CTCAE v4.03 Grade 4
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Aspartate Aminotransferase Increased

time Frame

1 year

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Preserved source evidence · Not medical advice