NCT02440464 · ADVERSE EVENTS

Adverse events

Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302) · Source last updated 2023-01-04

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 post-randomization
Other-event reporting threshold: 0%

Adverse event (AE) reporting was done using the BMT CTN's Manual of Procedures (MOP). Unexpected, grade 3-5 AE were reported through an expedited AE reporting system. Expected AEs were reported using National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at regular intervals as defined on the Form Submission Schedule and reported in the secondary outcome "Toxicities". All fatal (Grade 5) expected adverse events were reported in an expedited manner.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ixazomib Maintenance Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.	11 / 21	4 / 21	1 / 21
Placebo Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance. Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.	12 / 22	7 / 22	3 / 22
Enrolled Not Randomized Participants who enrolled in the study but were not randomized to treatment.	7 / 14	2 / 14	5 / 14

Group identifiers: EG000: Ixazomib Maintenance · EG001: Placebo · EG002: Enrolled Not Randomized

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
3
num At Risk
21
num Events
3
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Haemolytic anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Thrombotic microangiopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Atrial tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pericarditis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Cryptitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
2
num At Risk
22
num Events
2
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
2
num At Risk
22
num Events
2
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Graft versus host disease

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
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Influenza like illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
3
num At Risk
21
num Events
3
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Graft versus host disease in gastrointestinal tract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Myalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Posterior reversible encephalopathy syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pulmonary fibrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Deep vein thrombosis

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
21
description
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
id
EG000
other Num Affected
4
other Num At Risk
21
serious Num Affected
11
serious Num At Risk
21
title
Ixazomib Maintenance
deaths Num Affected
3
deaths Num At Risk
22
description
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance. Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
id
EG001
other Num Affected
7
other Num At Risk
22
serious Num Affected
12
serious Num At Risk
22
title
Placebo
deaths Num Affected
5
deaths Num At Risk
14
description
Participants who enrolled in the study but were not randomized to treatment.
id
EG002
other Num Affected
2
other Num At Risk
14
serious Num Affected
7
serious Num At Risk
14
title
Enrolled Not Randomized

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Influenza like illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
3
num At Risk
21
num Events
3
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Graft versus host disease in gastrointestinal tract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Myalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Posterior reversible encephalopathy syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pulmonary fibrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Deep vein thrombosis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
3
num At Risk
21
num Events
3
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Haemolytic anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Thrombotic microangiopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Atrial tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pericarditis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Cryptitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
2
num At Risk
22
num Events
2
group Id
EG002
num Affected
1
num At Risk
14
num Events
1
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
22
num Events
1
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
22
num Events
0
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
2
num At Risk
22
num Events
2
group Id
EG002
num Affected
0
num At Risk
14
num Events
0
term
Graft versus host disease

time Frame

2 years post-randomization

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

Preserved source evidence · Not medical advice