			9902-287	Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage.
4629	08/22/2002	04/30/2002		Study participant developed moderate itchiness, fatigue and moderate breathing problems the same day as receiving the gene transfer product. Two days later developed a fever to 102. The Investigator considered all these events possibly or probably related to the gene transfer product.
4630	08/22/2002	04/27/1999		The research participant developed low blood oxygen levels and difficulty breathing both during and after the procedure to instill the gene transfer product into the lungs and to obtain a lung biospy. The Investigator considered these events possibly related to the gene transfer product.
5024	10/10/2002	09/17/2002		Three hours after the bronchoscopic procedure to instill the gene transfer product into the lungs, the participant had an episode of low blood oxygen. This required supplemental oxygen be given, and the participant improved by the next day. The Investigator considered this possibly related to the gene transfer product.
5043	10/21/2002	09/17/2002		Follow up Investigator: Subject is now fully recovered from event.
5039	10/31/2002	09/17/2002		Follow up Investigator: Research participant fully recovered from the procedure and the low blood oxygen levels.
5025	10/10/2002	09/18/2002		Subject had mild shortness of breath the day after a bronchoscopic procedure was performed to instill the gene transfer product into the lungs. The symptoms resolved by the following day.
5040	10/21/2002	09/18/2002		Follow up Sponsor: Subject had mild shortness of breath one day after bronchoscopic procedure. Event resolved by the following day.
5041	10/21/2002	05/03/1999		Study participant experienced a mild/moderate breathing problem which the Investigator considered possibly related to the gene transfer product.
5042	10/21/2002	04/04/2000		Study participant developed mild cough, moderate shortness of breath with low blood oxygen levels, and mild vomiting. The Investigator considered all events possibly related to the gene transfer product.
			9910-346	A Phase II, Randomized, Multicenter, 26-Week Study to Assess the Efficacy and Safety of BioByPass® (ADGVVEGF121.10) Delivered Through Minimally Invasive Surgery Versus Maximum Medical Treatment in Patients with Severe Angina, Advanced Coronary Artery Disease, and No Options for Revascularization.
5031	10/29/2002	2001		This follow-up report notes that a new Sponsor has taken over the responsibility of this study. The new Sponsor's Medical Monitor concurred with the conclusions of the prior Sponsor in that the sequence of serious medical events appeared to have been initiated by the surgical procedure performed to administer the investigational agent.
			0002-388	A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, 52-Week Study to Assess the Safety and Efficacy of BioByPass® (ADGVVEGF121.10) in Peripheral Arterial Disease Patients with Severe, Disabling Intermittent Claudication.
4687	10/04/2002	2002		The subject died from progression of disease. The subject elected not to treat the underlying malignant disease, forgoing any biopsies or omentumectomy. No autopsy was performed.
			0005-395	A Phase I/II Trial Investigating the Safety and Immunotherapy of Adenovirus Encoding the Melan-A/MART-1 and gp100 Melanoma Antigens Administered Intradermally to Patients with Stage II-IV Melanoma.
4645	09/05/2002	08/14/2002		Four months after completing the study, the subject was found to have Stage 1 Follicular B-cell non-Hodgkins lymphoma. The Investigator considered this to be "unlikely related" to the investigational agent, but the Sponsor elected to consider this event "possibly related."
5052	10/15/2002	08/14/2002		Follow-up report Sponsor: Results of the retroperitoneal lymph node dissection. Three lymph nodes demonstrated a nodular poorly differentiated follicular center cell, B-cell lymphoma (nodular poorly differentiated lymphocytic lymphoma). These were CD-20 positive, CD-10 positive, and CD-5 negative.
			0101-452	A Multicenter, Randomized, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate the Efficacy and Safety of Ad5.1FGF-4 in Patients with Stable Angina.
4631	08/26/2002	08/24/2002		Approximately three weeks after receiving the blinded investigational agent, the research participant presented to the local ER with chest pain. The participant had been evaluated outside of the hospital two days prior for similar chest pain and a chest xray at that time showed a possible early pneumonia. The participant was admitted. Subsequent evaluation revealed a suspected non-ST segment elevation myocardial infarction.
4666	09/18/2002	08/24/2002		Follow-up Investigator: On the third hospital day, the research participant underwent successful angioplasty with stent placement. In the interval between the study agent administration and this admission there had been an increase in the size of the lesion in the saphenous vein graft.
			0107-481	An Open-Label, Phase Ib/II Study of the Safety, Tolerability and Efficacy of G207, a Genetically Engineered Herpes Simplex Type-1 Virus, Administered Intracerebrally to Subjects with Recurrent Malignant Glioma.
4664	09/13/2002	09/05/2002		After a brain tumor biopsy and injection of the gene transfer product into the tumor, research participant experienced a seizure. Two days later, participant had the tumor removed and additional gene transfer product injected into the surgical bed. That day the research participant experienced another seizure. This participant has had prior seizures and had low blood levels of dilantin (a medicine used to control seizures) at the time of the two events described above. The investigator considered that the two seizures were possibly related to the gene transfer product.
4670	09/23/2002	09/05/2002		Follow up Sponsor: The study participant had a CT scan of the brain that did not reveal an obvious cause for the seizures. The study participant has also developed left-sided weakness. The Sponsor considered the left-sided weakness and the seizures possibly related to the gene transfer product.
4669	09/20/2002	09/18/2002		Follow-up to event 4664. The study participant became less responsive and more difficult to arouse. Transferred to the neurologic intensive care unit for further evaluation. Repeat CT scan showed slight increase in the size of the brain ventricles and additional testing was performed, but the results are pending at the time of this report.
4689	10/02/2002	09/18/2002		Follow-up report Sponsor: Additional testing has not revealed a definitive cause of the seizures and change in mental status, but the Investigator and the Sponsor consider these events as possibly related to the gene transfer product.
			0107-493	A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients with Metastatic Hormone-Refractory Prostate Cancer.
4671	09/20/2002	09/11/2002		Sixteen days after last vaccine dose received, research participant presented with a headache and mental status changes. A CT scan of the head revealed a subdural hematoma, and participant also had a significant anemia and thrombocytopenia considered to be possibly related to the study agent. The participant was discharged to a hospice unit.
4679	10/01/2002	2002		Research participant died secondary to progressive disease and subdural hematoma.
			0203-519	A Phase II Trial of CG8020 and CG2505 in Patients with Nonresectable or Metastatic Pancreatic Cancer.
4692	10/07/2002	09/28/2002		Research participant was admitted with increasing diarrhea, weakness, fatigue, and poor oral intake over several days. The participant had received two doses of gene transfer vaccine, 4 weeks and 1.5 weeks prior to these events. The participant was treated with intravenous fluids. The Investigator considered these symptoms possibly related to gene transfer product.
4693	10/07/2002	2002		Follow-up to event 4692. The subject expired. Additional details are pending. The Investigator considered the events leading to death as possibly related to the gene transfer product.