BMT CTN 1702 Adverse Event Form

Registry Use Only Sequence Number:

Date Received:

CIBMTR Center Number: ______

CIBMTR Research ID: ______

Event date: ______/ __ __ / __ __ YYYY MM DD

CIBMTR Form 2535 revision 1 (page 1 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

Adverse Event Details

1. Was the adverse event related to the study consent process, collection of optional research blood samples, or completing QOL surveys? ☐ Yes 2. Specify which study procedure the adverse event is related to: ☐ No - Go to signature line ☐ Completing QOL surveys ☐ Optional research blood sample collection ☐ Study consent process ☐ Other 3. Specify other:______

4. Adverse event onset date: ______/ __ __ / __ __ YYYY MM DD

5. Date center became aware of the adverse event: ______/ __ __ / __ __ YYYY MM DD

6. Adverse event description:______

7. CTCAE system organ class: ☐ Blood and lymphatic system disorders ☐ Cardiac disorders ☐ Congenital, familial and genetic disorders ☐ Ear and labyrinth disorders ☐ Endocrine disorders ☐ Eye disorders ☐ Gastrointestinal disorders ☐ General disorders and administration site conditions ☐ Hepatobiliary disorders ☐ Immune system disorders ☐ Infections and infestations ☐ Injury, poisoning and procedural complications ☐ Investigations ☐ Metabolism and nutrition disorders ☐ Musculoskeletal and connective tissue disorders ☐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ☐ Nervous system disorders ☐ Pregnancy, puerperium and perinatal conditions ☐ Psychiatric disorders ☐ Renal and urinary disorders ☐ Reproductive system and breast disorders ☐ Respiratory, thoracic and mediastinal disorders ☐ Skin and subcutaneous tissue disorders ☐ Social circumstances ☐ Surgical and medical procedures ☐ Vascular disorders

CIBMTR Form 2535 revision 1 (page 2 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

8. CTCAE term: ☐ Anemia ☐ Ventricular fibrillation ☐ Retinal detachment ☐ Blood and lymphatic system disorders - ☐ Ventricular tachycardia ☐ Retinal tear Other, specify - Go to question 9 ☐ Congenital, familial and genetic ☐ Retinal vascular disorder Bone marrow hypocellular disorders - Other, specify ☐ Retinopathy - Go to question 9 ☐ Disseminated intravascular coagulation ☐ Scleral disorder Ear and labyrinth disorders - Other, ☐ ☐ Eosinophilia ☐ specify - Go to question 9 ☐ Uveitis Febrile neutropenia ☐ ☐ Ear pain ☐ Vision decreased Hemolysis ☐ ☐ External ear pain ☐ Vitreous hemorrhage Hemolytic uremic syndrome ☐ ☐ Hearing impaired ☐ Watering eyes Leukocytosis ☐ ☐ Middle ear inflammation ☐ Abdominal distension Lymph node pain ☐ ☐ Tinnitus ☐ Abdominal pain Methemoglobinemia ☐ ☐ Vertigo ☐ Anal fissure Thrombotic thrombocytopenic purpura ☐ ☐ Vestibular disorder ☐ Anal fistula Aortic valve disease ☐ ☐ Adrenal insufficiency ☐ Anal hemorrhage Asystole ☐ ☐ Cushingoid ☐ Anal mucositis Atrial fibrillation ☐ ☐ Delayed puberty ☐ Anal necrosis Atrial flutter ☐ ☐ Endocrine disorders - Other, specify ☐ Anal pain Atrioventricular block complete - Go to question 9 ☐ ☐ Anal stenosis Atrioventricular block first degree Growth accelerated ☐ ☐ ☐ Anal ulcer Cardiac arrest Hyperparathyroidism ☐ ☐ ☐ Ascites Cardiac disorders - Other, specify Hyperthyroidism ☐ ☐ Belching - Go to question 9 ☐ Hypoparathyroidism ☐ Bloating Chest pain - cardiac ☐ ☐ Hypophysitis ☐ Cecal hemorrhage Conduction disorder ☐ ☐ Hypopituitarism ☐ Cyanosis ☐ ☐ Hypothyroidism ☐ Chylous ascites Heart failure ☐ ☐ Precocious puberty ☐ Colitis Left ventricular systolic dysfunction ☐ ☐ Testosterone deficiency ☐ Colonic fistula Mitral valve disease ☐ ☐ Virilization ☐ Colonic hemorrhage Mobitz (type) II atrioventricular block ☐ ☐ Blurred vision ☐ Colonic obstruction Mobitz type I ☐ ☐ Cataract ☐ Colonic perforation Myocardial infarction ☐ ☐ Corneal ulcer ☐ Colonic stenosis Myocarditis ☐ ☐ Dry eye ☐ Colonic ulcer Palpitations ☐ ☐ Extraocular muscle paresis ☐ Constipation Paroxysmal atrial tachycardia ☐ ☐ Eye disorders - Other, specify ☐ ☐ Dental caries ☐ Pericardial effusion - Go to question 9 Diarrhea ☐ Pericardial tamponade ☐ Eye pain ☐ Dry mouth ☐ Pericarditis ☐ Eyelid function disorder ☐ Duodenal fistula ☐ Pulmonary valve disease ☐ Flashing lights ☐ Duodenal hemorrhage ☐ Restrictive cardiomyopathy ☐ Floaters ☐ Duodenal obstruction ☐ Right ventricular dysfunction ☐ Glaucoma ☐ Duodenal perforation ☐ Sick sinus syndrome ☐ Keratitis ☐ Duodenal stenosis ☐ Sinus bradycardia ☐ Night blindness ☐ Duodenal ulcer ☐ Sinus tachycardia ☐ Optic nerve disorder ☐ Dyspepsia ☐ Supraventricular tachycardia ☐ Papilledema ☐ Dysphagia ☐ Tricuspid valve disease ☐ Periorbital edema ☐ Enterocolitis ☐ Ventricular arrhythmia ☐ Photophobia ☐

CIBMTR Form 2535 revision 1 (page 3 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

☐ Enterovesical fistula ☐ Mucositis oral ☐ Edema limbs ☐ Esophageal fistula ☐ Nausea ☐ Edema trunk ☐ Esophageal hemorrhage ☐ Obstruction gastric ☐ Facial pain ☐ Esophageal necrosis ☐ Oral cavity fistula ☐ Fatigue ☐ Esophageal obstruction ☐ Oral dysesthesia ☐ Fever ☐ Esophageal pain ☐ Oral hemorrhage ☐ Flu like symptoms ☐ Esophageal perforation ☐ Oral pain ☐ Gait disturbance ☐ Esophageal stenosis ☐ Pancreatic duct stenosis ☐ General disorders and administration site conditions - Esophageal ulcer Pancreatic fistula ☐ ☐ Other, specify - Go to question 9 Esophageal varices hemorrhage Pancreatic hemorrhage ☐ ☐ ☐ Generalized edema Esophagitis Pancreatic necrosis ☐ ☐ ☐ Hypothermia Fecal incontinence Pancreatitis ☐ ☐ ☐ Infusion site extravasation Flatulence ☐ ☐ ☐ Injection site reaction Gastric fistula Peritoneal necrosis ☐ ☐ ☐ Localized edema Gastric hemorrhage Proctitis ☐ ☐ ☐ Malaise Gastric necrosis Rectal fissure ☐ ☐ ☐ Multi-organ failure Gastric perforation Rectal fistula ☐ ☐ ☐ Neck edema Gastric stenosis Rectal hemorrhage ☐ ☐ ☐ Non-cardiac chest pain Gastric ulcer Rectal mucositis ☐ ☐ ☐ Pain Gastritis Rectal necrosis ☐ ☐ ☐ Sudden death NOS Gastroesophageal reflux disease Rectal obstruction ☐ ☐ ☐ Vaccination site lymphadenopathy Gastrointestinal disorders - Other, Rectal pain ☐ ☐ Bile duct stenosis specify - Go to question 9 ☐ Rectal perforation ☐ Biliary fistula Gastrointestinal fistula ☐ ☐ Rectal stenosis ☐ Budd-Chiari syndrome Gastrointestinal pain ☐ ☐ Rectal ulcer ☐ Cholecystitis Gastroparesis ☐ ☐ Retroperitoneal hemorrhage ☐ Gallbladder fistula Gingival pain ☐ ☐ Salivary duct inflammation ☐ Gallbladder necrosis Hemorrhoidal hemorrhage ☐ ☐ Salivary gland fistula ☐ Gallbladder obstruction Hemorrhoids ☐ ☐ Small intestinal mucositis ☐ Gallbladder pain Ileal fistula ☐ ☐ Small intestinal obstruction ☐ Gallbladder perforation Ileal hemorrhage ☐ ☐ Small intestinal perforation ☐ Hepatic failure Ileal obstruction ☐ ☐ Small intestinal stenosis ☐ Hepatic hemorrhage Ileal perforation ☐ ☐ Small intestine ulcer ☐ Hepatic necrosis Ileal stenosis ☐ ☐ Stomach pain ☐ Hepatic pain Ileal ulcer ☐ ☐ Tooth development disorder ☐ Hepatobiliary disorders - Other, ☐ Ileus ☐ ☐ specify - Go to question 9 Intra-abdominal hemorrhage ☐ ☐ Toothache ☐ Perforation bile duct Jejunal fistula ☐ ☐ Typhlitis ☐ Portal hypertension Jejunal hemorrhage ☐ ☐ Upper gastrointestinal hemorrhage ☐ Portal vein thrombosis Jejunal obstruction ☐ ☐ Visceral arterial ischemia ☐ Sinusoidal obstruction syndrome Jejunal perforation ☐ ☐ Vomiting ☐ Allergic reaction Jejunal stenosis ☐ ☐ Chills ☐ Anaphylaxis Jejunal ulcer ☐ ☐ Death neonatal ☐ Autoimmune disorder pain ☐ ☐ Death NOS ☐ Cytokine release syndrome Lower gastrointestinal hemorrhage ☐ ☐ Disease progression ☐ Immune system disorders - Other, Malabsorption specify - Go to question 9 ☐ ☐ Edema face

CIBMTR Form 2535 revision 1 (page 4 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

☐ Serum sickness ☐ Lymph gland infection ☐ Arterial injury ☐ Abdominal infection ☐ Mediastinal infection ☐ Biliary anastomotic leak ☐ Anorectal infection ☐ Meningitis ☐ Bladder anastomotic leak ☐ Appendicitis ☐ Mucosal infection ☐ Bruising ☐ Appendicitis perforated ☐ Myelitis ☐ Burn ☐ Arteritis infective ☐ Nail infection ☐ Dermatitis radiation ☐ Bacteremia ☐ Otitis externa ☐ Esophageal anastomotic leak ☐ Biliary tract infection ☐ Otitis media ☐ Fall ☐ Bladder infection ☐ Ovarian infection ☐ Fallopian tube anastomotic leak ☐ Bone infection ☐ Pancreas infection ☐ Fallopian tube perforation ☐ Breast infection ☐ Papulopustular rash ☐ Fracture ☐ Bronchial infection ☐ Paronychia ☐ Gastric anastomotic leak ☐ Catheter related infection ☐ Pelvic infection ☐ Gastrointestinal anastomotic leak ☐ Cecal infection ☐ Penile infection ☐ Gastrointestinal stoma necrosis ☐ Cervicitis infection ☐ Periorbital infection ☐ Hip fracture ☐ Conjunctivitis ☐ Peripheral nerve infection ☐ Infusion related reaction ☐ Conjunctivitis infective ☐ Peritoneal infection ☐ Injury to carotid artery ☐ Corneal infection ☐ Pharyngitis ☐ Injury to inferior vena cava ☐ Cranial nerve infection ☐ Phlebitis infective ☐ Injury to jugular vein ☐ Cytomegalovirus infection reactivation ☐ Pleural infection ☐ Injury to superior vena cava ☐ Device related infection ☐ Prostate infection ☐ Injury, poisoning and procedural complications - Other, specify Duodenal infection Rash pustular ☐ ☐ - Go to question 9 Encephalitis infection Rhinitis infective ☐ ☐ ☐ Intestinal stoma leak Encephalomyelitis infection Salivary gland infection ☐ ☐ ☐ Intestinal stoma obstruction Endocarditis infective Scrotal infection ☐ ☐ ☐ Intestinal stoma site bleeding Endophthalmitis Sepsis ☐ ☐ ☐ Intraoperative arterial injury Enterocolitis infectious ☐ ☐ ☐ Intraoperative breast injury Epstein-Barr virus infection reactivation Sinusitis ☐ ☐ ☐ Intraoperative cardiac injury Esophageal infection Skin infection ☐ ☐ ☐ Intraoperative ear injury Eye infection Small intestine infection ☐ ☐ ☐ Intraoperative endocrine injury Folliculitis Soft tissue infection ☐ ☐ ☐ Intraoperative gastrointestinal ☐ Fungemia ☐ Splenic infection injury ☐ Gallbladder infection ☐ Stoma site infection ☐ Intraoperative head and neck injury ☐ Gum infection ☐ Thrush ☐ Intraoperative hemorrhage ☐ Hepatic infection ☐ Tooth infection ☐ Intraoperative hepatobiliary injury ☐ Hepatitis B reactivation ☐ Tracheitis ☐ Intraoperative musculoskeletal injury ☐ Hepatitis viral ☐ Upper respiratory infection ☐ Intraoperative neurological injury ☐ reactivation ☐ Urethral infection ☐ Intraoperative ocular injury ☐ Infections and infestations - Other, specify ☐ Urinary tract infection Intraoperative renal injury - Go to question 9 ☐ Uterine infection ☐ Infective myositis Intraoperative reproductive tract ☐ Vaginal infection ☐ ☐ injury Joint infection ☐ Viremia ☐ Intraoperative respiratory injury Kidney infection ☐ ☐ Vulval infection ☐ Intraoperative splenic injury Laryngitis ☐ ☐ Wound infection ☐ Intraoperative urinary injury Lip infection ☐ ☐ Ankle fracture ☐ Intraoperative venous injury Lung infection ☐ ☐ Aortic injury ☐ ☐ Kidney anastomotic leak

CIBMTR Form 2535 revision 1 (page 5 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

☐ Large intestinal anastomotic leak ☐ Cardiac troponin I increased ☐ Hypoalbuminemia ☐ Pancreatic anastomotic leak ☐ Cardiac troponin T increased ☐ Hypocalcemia

☐ Pharyngeal anastomotic leak ☐ CD4 lymphocytes decreased ☐ Hypoglycemia ☐ Postoperative hemorrhage ☐ Cholesterol high ☐ Hypokalemia ☐ Postoperative thoracic procedure complication ☐ CPK increased ☐ Hypomagnesemia ☐ Prolapse of intestinal stoma ☐ Creatinine increased ☐ Hyponatremia ☐ Prolapse of urostomy ☐ Ejection fraction decreased ☐ Hypophosphatemia ☐ Radiation recall reaction (dermatologic) ☐ Electrocardiogram QT corrected interval ☐ Iron overload prolonged ☐ Rectal anastomotic leak ☐ Metabolism and nutrition disorders ☐ Electrocardiogram T wave abnormal - Other, specify - Go to question 9 ☐ Seroma ☐ Fibrinogen decreased ☐ Obesity ☐ Small intestinal anastomotic leak ☐ Forced expiratory volume decreased ☐ Tumor lysis syndrome ☐ Spermatic cord anastomotic leak ☐ GGT increased ☐ Abdominal soft tissue necrosis ☐ Spinal fracture ☐ Growth hormone abnormal ☐ Arthralgia ☐ Stenosis of gastrointestinal stoma ☐ Haptoglobin decreased ☐ Arthritis ☐ Stomal ulcer ☐ Hemoglobin increased ☐ Avascular necrosis ☐ Tracheal hemorrhage ☐ INR increased ☐ Back pain ☐ Tracheal obstruction Investigations - Other, specify Bone pain Tracheostomy site bleeding ☐ ☐ ☐ - Go to question 9 Buttock pain Ureteric anastomotic leak ☐ ☐ Lipase increased ☐ Chest wall necrosis Urethral anastomotic leak ☐ ☐ Lymphocyte count decreased ☐ Chest wall pain Urostomy leak ☐ ☐ Lymphocyte count increased ☐ Exostosis Urostomy obstruction ☐ ☐ Neutrophil count decreased ☐ Fibrosis deep connective tissue Urostomy site bleeding ☐ ☐ Pancreatic enzymes decreased ☐ Flank pain Urostomy stenosis ☐ ☐ Platelet count decreased ☐ Generalized muscle weakness Uterine anastomotic leak ☐ ☐ Serum amylase increased ☐ Growth suppression Uterine perforation ☐ ☐ Thyroid stimulating hormone increased ☐ Head soft tissue necrosis Vaccination complication ☐ ☐ Urine output decreased ☐ Joint effusion Vaginal anastomotic leak ☐ ☐ Vital capacity abnormal ☐ Joint range of motion decreased Vas deferens anastomotic leak ☐ ☐ Weight gain ☐ Joint range of motion decreased Vascular access complication ☐ ☐ ☐ Weight loss cervical spine Venous injury ☐ ☐ White blood cell decreased ☐ Joint range of motion decreased Wound complication lumbar spine ☐ ☐ Acidosis Wound dehiscence Kyphosis ☐ ☐ Alcohol intolerance ☐ Wrist fracture Lordosis ☐ ☐ Alkalosis ☐ Activated partial thromboplastin time prolonged Muscle cramp ☐ ☐ Anorexia ☐ Alanine aminotransferase increased Muscle weakness lower limb ☐ ☐ Dehydration ☐ Alkaline phosphatase increased Muscle weakness trunk ☐ ☐ Glucose intolerance ☐ Aspartate aminotransferase increased Muscle weakness upper limb ☐ ☐ Hypercalcemia ☐ Blood antidiuretic hormone abnormal Musculoskeletal and connective ☐ Hyperglycemia ☐ ☐ tissue disorder - Other, specify Blood bicarbonate decreased ☐ ☐ Hyperkalemia - Go to question 9 Blood bilirubin increased ☐ ☐ Hyperlipidemia ☐ Musculoskeletal deformity Blood corticotrophin decreased ☐ ☐ Hypermagnesemia ☐ Myalgia Blood gonadotrophin abnormal ☐ ☐ Hypernatremia ☐ Myositis Blood lactate dehydrogenase increased ☐ ☐ Hyperphosphatemia ☐ Neck pain Blood prolactin abnormal ☐ ☐ Hypertriglyceridemia ☐ Neck soft tissue necrosis Carbon monoxide diffusing capacity decreased ☐ ☐ Hyperuricemia ☐ Osteonecrosis

CIBMTR Form 2535 revision 1 (page 6 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

☐ Osteonecrosis of jaw ☐ Glossopharyngeal nerve disorder ☐ Pregnancy loss ☐ Osteoporosis ☐ Guillain-Barre syndrome ☐ Pregnancy, puerperium and perinatal conditions - Other, Pain in extremity Headache ☐ ☐ specify - Go to question 9 Pelvic soft tissue necrosis Hydrocephalus ☐ ☐ ☐ Premature delivery Rhabdomyolysis Hypersomnia ☐ ☐ ☐ Agitation Rotator cuff injury Hypoglossal nerve disorder ☐ ☐ ☐ Anorgasmia Scoliosis Intracranial hemorrhage ☐ ☐ ☐ Anxiety Soft tissue necrosis lower limb Ischemia cerebrovascular ☐ ☐ ☐ Confusion Soft tissue necrosis upper limb Lethargy ☐ ☐ ☐ Delayed orgasm Superficial soft tissue fibrosis Leukoencephalopathy ☐ ☐ ☐ Delirium Memory impairment ☐ ☐ ☐ Delusions Unequal limb length Meningismus ☐ ☐ ☐ Depression Leukemia secondary to oncology chemotherapy Movements involuntary ☐ ☐ ☐ Euphoria Myelodysplastic syndrome Muscle weakness left-sided ☐ ☐ ☐ Hallucinations Neoplasms benign, malignant and unspecified (incl Muscle weakness right-sided ☐ ☐ Insomnia cysts and polyps) - Other, specify ☐ ☐ Myasthenia gravis - Go to question 9 ☐ Irritability Nervous system disorders - Other, Skin papilloma ☐ Libido decreased ☐ specify - Go to question 9 ☐ Treatment related secondary malignancy Libido increased ☐ ☐ Neuralgia ☐ Tumor hemorrhage Mania ☐ ☐ Nystagmus ☐ Tumor pain Personality change ☐ ☐ Oculomotor nerve disorder ☐ Abducens nerve disorder Psychiatric disorders - Other, ☐ Olfactory nerve disorder ☐ ☐ specify - Go to question 9 Accessory nerve disorder ☐ Paresthesia ☐ Psychosis Acoustic nerve disorder NOS ☐ ☐ Peripheral motor neuropathy ☐ Restlessness Akathisia ☐ ☐ Peripheral sensory neuropathy ☐ Suicidal ideation Amnesia ☐ ☐ Phantom pain ☐ Suicide attempt Anosmia ☐ ☐ Presyncope ☐ Acute kidney injury Aphonia ☐ ☐ Pyramidal tract syndrome ☐ Bladder perforation Arachnoiditis ☐ ☐ Radiculitis ☐ Bladder spasm Ataxia ☐ ☐ Recurrent laryngeal nerve palsy ☐ Chronic kidney disease Brachial plexopathy ☐ ☐ Reversible posterior ☐ ☐ Cystitis noninfective ☐ Central nervous system necrosis leukoencephalopathy syndrome ☐ Dysuria ☐ Cerebrospinal fluid leakage ☐ Seizure ☐ Glucosuria ☐ Cognitive disturbance ☐ Somnolence ☐ Hematuria ☐ Concentration impairment ☐ Spasticity ☐ Hemoglobinuria ☐ Depressed level of consciousness ☐ Spinal cord compression ☐ Nephrotic syndrome ☐ Dizziness ☐ Stroke ☐ Proteinuria ☐ Dysarthria ☐ Syncope Renal and urinary disorders - Dysesthesia Tendon reflex decreased ☐ ☐ ☐ Other, specify - Go to question 9 Dysgeusia Transient ischemic attacks ☐ ☐ ☐ Renal calculi Dysphasia Tremor ☐ ☐ ☐ Renal colic Edema cerebral Trigeminal nerve disorder ☐ ☐ ☐ Renal hemorrhage Encephalopathy Trochlear nerve disorder ☐ ☐ ☐ Urinary fistula Extrapyramidal disorder Vagus nerve disorder ☐ ☐ ☐ Urinary frequency Facial muscle weakness Vasovagal reaction ☐ ☐ ☐ Urinary incontinence Facial nerve disorder Fetal growth retardation ☐ ☐ ☐ Urinary retention

CIBMTR Form 2535 revision 1 (page 7 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

☐ Urinary tract obstruction ☐ Vaginal dryness ☐ Pleural hemorrhage ☐ Urinary tract pain ☐ Vaginal fistula ☐ Pleuritic pain ☐ Urinary urgency ☐ Vaginal hemorrhage ☐ Pneumonitis ☐ Urine discoloration ☐ Vaginal inflammation ☐ Pneumothorax ☐ Amenorrhea ☐ Vaginal obstruction ☐ Postnasal drip ☐ Azoospermia ☐ Vaginal pain ☐ Productive cough ☐ Breast atrophy ☐ Vaginal perforation ☐ Pulmonary edema ☐ Breast pain ☐ Vaginal stricture ☐ Pulmonary fibrosis ☐ Dysmenorrhea ☐ Adult respiratory distress syndrome ☐ Pulmonary fistula ☐ Dyspareunia ☐ Allergic rhinitis ☐ Pulmonary hypertension ☐ Ejaculation disorder ☐ Apnea ☐ Respiratory failure ☐ Erectile dysfunction ☐ Aspiration ☐ Respiratory, thoracic and mediastinal disorders - Other, ☐ Fallopian tube obstruction Atelectasis ☐ specify ☐ Feminization acquired Bronchial fistula ☐ ☐ Retinoic acid syndrome ☐ Genital edema Bronchial obstruction ☐ ☐ Rhinorrhea ☐ Gynecomastia Bronchial stricture ☐ ☐ Sinus disorder ☐ Hematosalpinx Bronchopleural fistula ☐ ☐ Sinus pain ☐ Irregular menstruation Bronchopulmonary hemorrhage ☐ ☐ Sleep apnea ☐ Lactation disorder Bronchospasm ☐ ☐ Sneezing ☐ Menorrhagia Chylothorax ☐ ☐ Sore throat ☐ Nipple deformity Cough ☐ ☐ Stridor ☐ Oligospermia Dyspnea ☐ ☐ Tracheal fistula ☐ Ovarian hemorrhage Epistaxis ☐ ☐ Tracheal mucositis ☐ Ovarian rupture Hiccups ☐ ☐ Tracheal stenosis ☐ Ovulation pain Hoarseness ☐ ☐ Voice alteration ☐ Pelvic floor muscle weakness Hypoxia ☐ ☐ Wheezing ☐ Pelvic pain Laryngeal edema ☐ ☐ Alopecia ☐ Penile pain Laryngeal fistula ☐ ☐ Body odor ☐ Perineal pain Laryngeal hemorrhage ☐ ☐ Bullous dermatitis ☐ Premature menopause Laryngeal inflammation ☐ ☐ Dry skin ☐ Prostatic hemorrhage Laryngeal mucositis ☐ ☐ Eczema ☐ Prostatic obstruction Laryngeal obstruction ☐ ☐ ☐ Prostatic pain Laryngeal stenosis ☐ ☐ Erythroderma ☐ Reproductive system and breast disorders ☐ Laryngopharyngeal dysesthesia - Other, specify - Go to question 9 ☐ Fat atrophy ☐ Laryngospasm ☐ Scrotal pain ☐ Hair color changes ☐ Mediastinal hemorrhage ☐ Spermatic cord hemorrhage ☐ Hair texture abnormal ☐ Nasal congestion ☐ Spermatic cord obstruction ☐ Hirsutism ☐ Oropharyngeal pain ☐ Testicular disorder ☐ Hyperhidrosis ☐ Pharyngeal fistula ☐ Testicular hemorrhage ☐ Hyperkeratosis ☐ Pharyngeal hemorrhage ☐ Testicular pain ☐ Hypertrichosis ☐ Pharyngeal mucositis ☐ Uterine fistula ☐ Hypohidrosis ☐ Pharyngeal necrosis ☐ Uterine hemorrhage ☐ Lipohypertrophy ☐ Pharyngeal stenosis ☐ Uterine obstruction ☐ Nail changes ☐ Pharyngolaryngeal pain ☐ Uterine pain ☐ Nail discoloration ☐ Pleural effusion ☐ Vaginal discharge ☐ Nail loss

CIBMTR Form 2535 revision 1 (page 8 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

☐ Nail ridging ☐ Skin induration ☐ Hot flashes ☐ Pain of skin ☐ Skin ulceration ☐ Hypertension ☐ Palmar-plantar erythrodysesthesia ☐ Stevens-Johnson syndrome ☐ Hypotension syndrome ☐ Subcutaneous emphysema ☐ Lymph leakage ☐ Photosensitivity ☐ Telangiectasia ☐ Lymphedema ☐ Pruritus ☐ Toxic epidermal necrolysis ☐ Lymphocele ☐ Purpura ☐ Urticaria ☐ Peripheral ischemia ☐ Rash acneiform ☐ Social circumstances - Other, specify ☐ Phlebitis ☐ Rash maculo-papular - Go to question 9 ☐ Superficial thrombophlebitis ☐ Scalp pain Surgical and medical procedures - ☐ ☐ Superior vena cava syndrome ☐ Skin and subcutaneous tissue disorders - Other, specify - Go to question 9 Thromboembolic event Other, specify - Go to question 9 ☐ Arterial thromboembolism ☐ Vascular disorders - Other, specify ☐ Skin atrophy Capillary leak syndrome ☐ ☐ - Go to question 9 ☐ Skin hyperpigmentation Flushing ☐ ☐ Vasculitis ☐ Skin hypopigmentation ☐ Hematoma

9. Specify other:______

10. CTCAE grade (most severe) ☐ Grade 1 ☐ Grade 2 ☐ Grade 3 ☐ Grade 4 ☐ Grade 5

11. Which of the SAE criteria was the adverse event associated with? ☐ None of the following ☐ Death ☐ Life-threatening situation ☐ Inpatient hospitalization or prolongation of existing hospitalization ☐ Persistent or significant disability / incapacity or substantial disruption of the ability to conduct normal life functions ☐ Congenital anomaly / birth defect ☐ An important medical event that requires intervention to prevent one of the above outcomes ☐ Other 12. Specify other:______

13. Was the adverse event expected? ☐ Yes ☐ No

14. What is the relationship between the reported adverse event and the study procedure(s)? ☐ Unrelated ☐ Unlikely ☐ Possible ☐ Probable ☐ Definite

15. Is there an alternative etiology? ☐ Accident, trauma, or external factors ☐ Concurrent illness / condition (not pre-existing) ☐ None apparent ☐ Study disease ☐ Other pre-existing disease or condition ☐ Other 16. Specify other alternative etiology:______

CIBMTR Form 2535 revision 1 (page 9 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. CIBMTR Center Number: ______CIBMTR Research ID: ______

17. What action was taken with study procedures? ☐ No change ☐ Study procedure temporarily suspended ☐ Subject taken off study – Also complete BMT CTN Off Study Form 2536 ☐ Other 18. Specify other action taken:______

19. Adverse event outcome: ☐ Currently recovering / currently resolving ☐ Fatal adverse event ☐ Not recovered / not resolved ☐ Recovered / resolved 20. Date of resolution: ______/ __ __ / __ __ ☐ Resolved with sequalae YYYY MM DD

First Name:______

Last Name:______

E-mail address:______

Date: ______/ __ __ / __ __ YYYY MM DD

CIBMTR Form 2535 revision 1 (page 10 of 10). Form released July, 2019. Last Updated July, 2019. Copyright (c) 2019 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.