The Wright Center for Graduate Medical Education

WCGME-IRB

The Wright Center for Graduate Medical Education

Institutional Review Board

Date: February 2, 2015

Submitted by:Martin Hyzinski M.D. Address: 743 Jefferson Ave Suite 205 Scranton, PA 18510

Telephone: 570-558-3020

Adverse Event and IND Safety Report Template:

Organization and Protocol Number: / Patient Identifier: / Date: / Initial: / FU: / Adverse Event / Safety Report: /
Millennium
16010
16014 / 12/08/2014
12/10/2014
12/12/2014
12/15/2014
12/17/2014
12/19/2014
12/22/14
12/26/2014
12/29/2014
12/31/2014
1/2/2015
1/5/2015
1/7/2015
1/9/2015
1/12/2015
1/14/2015
1/16/2015
1/19/2015
1/21/2015
1/23/2015
1/26/2015
1/28/2015
1/30/2015
2/2/2015 / MLN9708 Safety Updates
2014MPI001547 fu 2- sepsis, febrile neutropenia, rash macula- popular
2014MPI003021 fu 1 – cardiac failure
2014MPI003189 initial -pulmonary edema
2013MPI001452 fu 4 gout
2014 fu 4 MI
2014MPI001825 fu 2 urosepsis, DVT, hyperthermia
2014MPI003062 fu 1 psoriasis
2014MPI003075 fu 1 pancytopenia
2014MPI003180 initial- peripheral edema
2014MPI003213 initial- back pain, acute renal failure
2014TJP016426 initial- back pain, acute renal failure
2013-03193-fu 5 – pseudomonas pneumonia
2013-05519 fu 3 – febrile neutropenia, skin infection, convulsion, ARDS
2014MPI001861 initial- skin infection, febrile neutropenia, septic shock, convulsion, ARDS
2014MPI002945 fu 2 pneumonia
2014MPI003090 initial hypokalemia, facial edema, peripheral edema
2014MPI003200 initial- malaise, fatigue,pyrexia
2014MPI003237 initial- abdominal adhesions
2014MPI003238 initial – cardiac failure
2014MPI003241 initial- weakness
2014MPI002201 fu 3 – influenza, staph infection
2014MPI002285 fu 1- dehydration, anemia
2014MPI002355 fu 4 arrhythmia
2014MPI002621 fu 4 atrial flutter
2014MPI002980 fu3 pulmonary edema
2014MPI003021 fu 2- cardiac failure
2014MPI003151 fu 1- peripheral artery thrombosis, cardiac arrest
2014MPI003189 fu 1 – pulmonary edema
2014MPI003243 initial- bile duct cancer
2014MPI003262 initial- phlebitis, pulmonary embolism
2014MPI003286 initial- incision site erythema
2014MPI001316 initial- second primary malignancy
2014MPI001328 fu 7 convulsion
2014MPI003090 fu 1 – hypokalemia, facial edema, peripheral edema
2014MPI003138 fu 1 – pneumonia
2014MPI003306 initial- fall, radius fracture
2014MPI003316 initial- pulmonary infection
2014MPI003318 initial – infectious colitis, gastroenteritis
2014MPI003323 initial- MI, Cardiac arrest
2014MPI003347 initial – sepsis
2014TJP016426 fu 1 – back pain, acute renal failure
2014MPI000527 fu 1- acute polyneuropathy
2014MPI001861 fu 1- skin infection, febrile neutropenia, septic shock, convulsion, ARDS
2014MPI002315 initial- pneumonia
2014MPI002596 fu 3- septic shock
2014MPI003100 fu2 COPD
2014MPI003317 initial- hypertensive crisis
2014MPI003325 initial- sepsis
2014MPI003341 initial- general weakness
2014MPI001373 fu7 –syncope, fall
2014MPI002402 fu3 – myelodysplastic syndrome, pneumonia
2014MPI002945 fu 3 pneumonia
2014MPI003241 fu1 asthenia, bronchopneumonia, myeloma progression
2014MPI003331 initial- chest pain
2014MPI003344 initial- diabetic ketoacidosis, systemic inflammatory response syndrome, atrial fibrillation, cellulitis staphylococcal, acute renal failure
2014MPI003361 initial – pulmonary embolism
2014MPI003363 initial- bronchitis
2014MPI003381 initial pleural effusion
2014TJP016426 fu2 back pain, acute renal failure
2014MPI001316 fu 1 – second primary malignancy
2014MPI002621 fu5- atrial flutter
2014MPI003021 fu3- cardiac failure
2014MPI003286 fu 1- wound infection, squamous cell carcinoma of skin
2014MPI003316 fu1 – bronchitis
2014MPI003318 fu 1- gastroenteritis, infectious colitis
2014MPI003347 fu 1 – sepsis
2014MPI003394 initial- lung infection
2014MPI003409 initial- MI
2014MPI003436 initial- cerebral bleeding, thrombocytopenia
2014MPI002402 fu4- MDS, pneumonia
2014MPI003180 fu1- peripheral edema
2014MPI003262 fu 1- phlebitis, pulmonary embolism
2014MPI003317 fu1 – hypertensive crisis
2014MPI003387 initial – pneumonitis, neutrophilia
2014MPI00340 7 initial- acute renal failure
2014MPI003412 initial – rash
2014MPI003415 initial- lymphocyte count decreased
2014MPI003419 initial- rectal hemorrhage secondary to thrombocytopenia, thrombocytopenia
2014TJP017620 initial – pneumonia
2014MPI003306 fu 1- radius fracture, fall
2014MPI003325 fu1 – sepsis, lower respiratory tract infection
2014MPI003361 fu1 – pulmonary embolism
2014MPI003409 fu 1- angina
2014MPI002584 fu4 – general physical health deterioration, diarrhea
2014MPI002621 fu6 – atrial flutter
2014MPI003241 fu2 – weakness, bronchopneumonia, myeloma progression
2014MPI003286 fu 2- medically significant Rt
2014MPI003446 initial – acute renal failure, mental status change
2014MPI003451 initial- fever
2014MPI003455 initial- pneumonia, influenza
2014MPI003316fu2- bronchitis
2014MPI003363 fu1 –bronchitis
2014MPI003381 fu1 – pleural effusion
2014MPI003469 initial – chest pain
2014TJP017620 fu1 – pneumonia
2013MPI001049 fu 5 –gastroenteritis, pneumonia
2014MPI002980 fu4 – supraventricular tachycardia
2014MPI002990 fu1- basal cell carcinoma
2014MPI003151 fu 2- cardiac arrest, peripheral artery thrombosis
2015MPI000021 – initial- pneumonia
2015MPI000059 initial- Bronchitis, lung infection
2015MPI000077 initial- febrile neutropenia
2015MPI000090 initial – multi-organ failure
2014MPI001932 fu4 – tumor lysis syndrome
2014MPI002621 fu7 – supraventricular tachycardia
2014MPI002907 fu 1- edema
2014MPI003262 fu 2- phelebitis, pulmonary embolism
2014MPI003286 fu 3 – medically significant rt
2014MPI003451 fu1 fever
2014MPI003469 fu 1 – pulmonary embolism
2014TJP016426 fu3- back pain, acute renal failure
2014TJP017620 fu 2 – pneumonia
2015MPI000021 fu 1- pneumonia
2014MPI000200 fu 4- dehydration,pulmonary embolism, metastatic malignant melanoma
2014MPI001316 fu 3- second primary malignancy
2014MPI001316 fu3 – second primary
Malignancy
2014MPI003341 fu 1- asthenia
2015MPI000096 initial- pyrexia
2015MPI000101 initial- asthenia
2014MPI003446 fu1 acute renal failure, mental status changes
2014TJP017620fu3- pneumonia
2014MPI002196 fu2- bronchopulmonary aspergillosis
2014MPI002285 fu 2- anemia
2014MPI003361 fu2- pulmonary embolism
2015MPI000101 fu 1- asthenia, orthostatic hypotension
2015MPI000123 initial- back pain
2015MPI000161 initial- lymphocyte count decreased
2015MPI000168 initial- cardiac failure
2014MPI002845 fu 3 –UTI
2014MPI003316 fu3 bronchitis
2014MPI000131 initial – febrile neutropenia, pyrexia
2015MPI000185 initial- general health deterioration
2015MPI000206 initial- hypotension, anemia
2015MPI000258 initial- WBC decreased, neutrophils decreased
1508949 initial- sudden death, neutropenia, weakness, dehydration, colitis
2012-02891 fu 7 – dehydration, diarrhea, anorectal infection
2014MPI002402 fu5 – panycytopenia, pneumonia
2014MPI002841 fu 1- upper respiratory tract infection
2014MPI003446 fu 2- acute renal failure, mental status changes, blood creatinine increased
2015MPI000216 initial- osteonecrosis of jaw
2015MPI000281 initial- encephalopathy
2014MPI002458 fu 2- pneumonia
2014MPI002621 fu 6 supraventricular tachycardia
2014MPI002980 fu5 supraventricular tachycardia
2014MPI003119 fu 1 Herpes zoster
2014MPI003451 fu 2- fever
2014MPI003455 fu 1 pneumonia, influenza
2015MPI000059 fu1 bronchitis, lung infection
2015MPI000251 initial –RSV
2015MPI000264 initial dyspnea
2015MPI000267 initial- basal cell carcinoma
2014MPI003331 fu –asthma
2015MPI000077 fu1-febrile neutropenia
2015MPI000284 initial – dyspnea
2015MPI000288 initial- abdominal pain
Dendreon Proceed / Dendreon – sipuleucel- T
2013SIPUSA00016 fu 3- metastatic prostate cancer - death
S 1207 / 1/8/2015
1/22/2015 / Everolimus –
2086422 initial- gastrointestinal disorders: Dieulafay lesion, gastric hemorrhage
Cover Memo
PHHO2014FR016631 iridocyclitis
PHHO2014AR004429 brain edema, cardio- resp arrest, diarrhea, dehydration, gastric hemorrhage, decreased weight, tonic- clonic seizure, visual acuity decreased, gastroenteritis, vomiting, TIA
E5508 / 1/27/2015 / Patient # 55966 expired second to pneumonia.
E1305, E1609,
E 3612, E5103, E5202,E5204, E5508 / 1/28/2015 / Bevacizumab
#2630178-ISR- encephalopathy
E1609, E3612 / 1/28/2015 / MDX-010
2953661- hearing impaired

Rev 02/01/11